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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2021 

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from              to             

Commission File Number: 001-38112

 

ATHENEX, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

43-1985966

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

 

 

1001 Main Street, Suite 600

Buffalo, NY

14203

(Address of principal executive offices)

(Zip Code)

 

(716) 427-2950

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Exchange Act:

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.001 per share

 

ATNX

 

The Nasdaq Global Select Market

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.     Yes      No  

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes      No  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. 

 

Large accelerated filer

 

  

Accelerated filer

 

 

 

 

 

 

 

 

Non-accelerated filer

 

 

  

Small reporting company

 

 

 

 

 

 

 

 

Emerging growth company

 

 

 

 

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes      No  

 

As of July 31, 2021, the registrant had 109,307,740   shares of common stock, $0.001 par value per share, outstanding.

 

 

 

 


 

 

Table of Contents

 

 

 

 

 

Page

PART I.

 

FINANCIAL INFORMATION

 

1

Item 1.

 

Financial Statements

 

1

 

 

Condensed Consolidated Balance Sheets (Unaudited)

 

1

 

 

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

 

2

 

 

Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)

 

3

 

 

Condensed Consolidated Statements of Cash Flows (Unaudited)

 

4

 

 

Notes to Condensed Consolidated Financial Statements (Unaudited)

 

5

Item 2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

27

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

42

Item 4.

 

Controls and Procedures

 

42

PART II.

 

OTHER INFORMATION

 

43

Item 1.

 

Legal Proceedings

 

43

Item 1A.

 

Risk Factors

 

43

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

46

Item 3.

 

Defaults Upon Senior Securities

 

46

Item 4.

 

Mine Safety Disclosures

 

46

Item 5.

 

Other Information

 

46

Item 6.

 

Exhibits

 

47

Signatures

 

48

 

 

 

i


 

 

PART I—FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements.

ATHENEX, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(unaudited)

(In thousands, except share and per share data)

 

 

 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

76,941

 

 

$

69,587

 

Restricted cash

 

 

16,500

 

 

 

16,500

 

Short-term investments

 

 

53,283

 

 

 

138,636

 

Accounts receivable, net of chargebacks and other deductions of $14,523 and

   $12,552, respectively, and provision for credit losses of $9,421 and $9,637,

   respectively

 

 

22,218

 

 

 

23,603

 

Inventories

 

 

29,765

 

 

 

28,846

 

Prepaid expenses and other current assets

 

 

14,384

 

 

 

14,789

 

Total current assets

 

 

213,091

 

 

 

291,961

 

Property and equipment, net

 

 

45,685

 

 

 

34,388

 

Goodwill

 

 

69,216

 

 

 

38,891

 

Intangible assets, net

 

 

72,779

 

 

 

10,218

 

Operating lease right-of-use assets, net

 

 

7,019

 

 

 

7,921

 

Other assets

 

 

1,167

 

 

 

950

 

Total assets

 

$

408,957

 

 

$

384,329

 

Liabilities and stockholders' equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

19,467

 

 

$

18,673

 

Accrued expenses

 

 

35,612

 

 

 

38,273

 

Current portion of operating lease liabilities

 

 

3,119

 

 

 

3,185

 

Current portion of long-term debt and finance lease obligations

 

 

4,725

 

 

 

2,010

 

Total current liabilities

 

 

62,923

 

 

 

62,141

 

Long-term liabilities:

 

 

 

 

 

 

 

 

Long-term operating lease liabilities

 

 

5,317

 

 

 

6,355

 

Long-term debt and finance lease obligations

 

 

145,271

 

 

 

146,577

 

Deferred tax liabilities

 

 

1,833

 

 

 

56

 

Contingent consideration

 

 

20,237

 

 

 

 

Other long-term liabilities

 

 

3,496

 

 

 

3,852

 

Total liabilities

 

 

239,077

 

 

 

218,981

 

Commitments and contingencies (See Note 17)

 

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 

 

Common stock, par value $0.001 per share, 250,000,000 shares authorized at June 30,

   2021 and December 31, 2020; 110,980,660 and 95,066,195 shares issued at June 30,

   2021 and December 31, 2020, respectively; 109,307,740 and 93,393,275 shares

   outstanding at June 30, 2021 and December 31, 2020, respectively

 

 

111

 

 

 

95

 

Additional paid-in capital

 

 

966,666

 

 

 

901,864

 

Accumulated other comprehensive loss

 

 

(1,123

)

 

 

(1,134

)

Accumulated deficit

 

 

(772,968

)

 

 

(713,644

)

Less: treasury stock, at cost; 1,672,920 shares at June 30, 2021 and

   December 31, 2020

 

 

(7,485

)

 

 

(7,406

)

Total Athenex, Inc. stockholders' equity

 

 

185,201

 

 

 

179,775

 

Non-controlling interests

 

 

(15,321

)

 

 

(14,427

)

Total stockholders' equity

 

 

169,880

 

 

 

165,348

 

Total liabilities and stockholders' equity

 

$

408,957

 

 

$

384,329

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

1


 

ATHENEX, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations and Comprehensive Loss

(unaudited)

(In thousands, except share and per share data)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales, net

 

$

21,385

 

 

$

40,167

 

 

$

41,745

 

 

$

58,714

 

License and other revenue

 

 

538

 

 

 

5

 

 

 

21,203

 

 

 

28,393

 

Total revenue

 

 

21,923

 

 

 

40,172

 

 

 

62,948

 

 

 

87,107

 

Cost of sales

 

 

19,663

 

 

 

33,006

 

 

 

36,068

 

 

 

52,578

 

Gross Profit

 

 

2,260

 

 

 

7,166

 

 

 

26,880

 

 

 

34,529

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

 

21,127

 

 

 

22,015

 

 

 

44,197

 

 

 

39,207

 

Selling, general, and administrative expenses

 

 

21,231

 

 

 

17,486

 

 

 

43,351

 

 

 

43,234

 

Total operating expenses

 

 

42,358

 

 

 

39,501

 

 

 

87,548

 

 

 

82,441

 

Operating loss

 

 

(40,098

)

 

 

(32,335

)

 

 

(60,668

)

 

 

(47,912

)

Interest income

 

 

132

 

 

 

185

 

 

 

161

 

 

 

598

 

Interest expense

 

 

5,684

 

 

 

1,565

 

 

 

10,592

 

 

 

3,238

 

Loss on extinguishment of debt

 

 

 

 

 

7,230

 

 

 

 

 

 

7,230

 

Loss before income tax (benefit) expense

 

 

(45,650

)

 

 

(40,945

)

 

 

(71,099

)

 

 

(57,782

)

Income tax (benefit) expense

 

 

(11,035

)

 

 

106

 

 

 

(10,881

)

 

 

2,987

 

Net loss

 

 

(34,615

)

 

 

(41,051

)

 

 

(60,218

)

 

 

(60,769

)

Less: net loss attributable to non-controlling interests

 

 

(341

)

 

 

(600

)

 

 

(894

)

 

 

(889

)

Net loss attributable to Athenex, Inc.

 

$

(34,274

)

 

$

(40,451

)

 

$

(59,324

)

 

$

(59,880

)

Unrealized (loss) gain on investment, net of income taxes

 

 

(19

)

 

 

117

 

 

 

(3

)

 

 

49

 

Foreign currency translation adjustment, net of income taxes

 

 

(263

)

 

 

(43

)

 

 

14

 

 

 

(481

)

Comprehensive loss

 

$

(34,556

)

 

$

(40,377

)

 

$

(59,313

)

 

$

(60,312

)

Net loss per share attributable to Athenex, Inc. common

   stockholders, basic and diluted (See Note 14)

 

$

(0.33

)

 

$

(0.50

)

 

$

(0.60

)

 

$

(0.73

)

Weighted-average shares used in computing net loss per share

   attributable to Athenex, Inc. common stockholders, basic and

   diluted (See Note 14)

 

 

103,370,268

 

 

 

81,564,441

 

 

 

98,427,561

 

 

 

81,551,995

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

2


 

 

ATHENEX, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Stockholders’ Equity

(unaudited)

(In thousands, except share data)

 

 

Common Stock

 

 

Additional

 

 

 

 

 

 

Accumulated

other

 

 

Treasury Stock

 

 

Total

Athenex,

Inc.

 

 

Non-

 

 

Total

 

 

 

Shares

 

 

Amount

 

 

paid-in

capital

 

 

Accumulated

deficit

 

 

comprehensive

loss

 

 

Shares

 

 

Amount

 

 

stockholders'

equity

 

 

controlling

interests

 

 

stockholders'

equity

 

Balance at January 1, 2020

 

 

83,231,063

 

 

$

83

 

 

$

763,648

 

 

$

(567,465

)

 

$

(635

)

 

 

(1,672,920

)

 

$

(7,406

)

 

$

188,225

 

 

$

(12,370

)

 

$

175,855

 

Stock-based compensation cost

 

 

 

 

 

 

 

 

1,864

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,864

 

 

 

 

 

 

1,864

 

Restricted stock expense

 

 

(3,000

)

 

 

 

 

 

397

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

397

 

 

 

 

 

 

397

 

Stock options exercised

 

 

70,200

 

 

 

 

 

 

344

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

344

 

 

 

 

 

 

344

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(19,429

)

 

 

 

 

 

 

 

 

 

 

 

(19,429

)

 

 

(289

)

 

 

(19,718

)

Other comprehensive loss, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(506

)

 

 

 

 

 

 

 

 

(506

)

 

 

 

 

 

(506

)

Balance at March 31, 2020 (unaudited)

 

 

83,298,263

 

 

 

83

 

 

 

766,253

 

 

 

(586,894

)

 

 

(1,141

)

 

 

(1,672,920

)

 

 

(7,406

)

 

 

170,895

 

 

 

(12,659

)

 

 

158,236

 

Sale of common stock and issuance of stock in connection with acquisition

 

 

51,691

 

 

 

 

 

 

269

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

269

 

 

 

 

 

 

269

 

Stock-based compensation cost

 

 

 

 

 

 

 

 

2,640

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,640

 

 

 

 

 

 

2,640

 

Restricted stock expense

 

 

 

 

 

 

 

 

413

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

413

 

 

 

 

 

 

413

 

Stock options exercised

 

 

12,500

 

 

 

 

 

 

125

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

125

 

 

 

 

 

 

125

 

Issuance of warrants, net

 

 

 

 

 

 

 

 

5,342

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,342

 

 

 

 

 

 

5,342

 

Non-controlling interests

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

198

 

 

 

198

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(40,451

)

 

 

 

 

 

 

 

 

 

 

 

(40,451

)

 

 

(600

)

 

 

(41,051

)

Other comprehensive income, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

74

 

 

 

 

 

 

 

 

 

74

 

 

 

 

 

 

74

 

Balance at June 30, 2020 (unaudited)

 

$

83,362,454

 

 

$

83

 

 

$

775,042

 

 

$

(627,345

)

 

$

(1,067

)

 

 

(1,672,920

)

 

$

(7,406

)

 

$

139,307

 

 

$

(13,061

)

 

$

126,246

 

 

 

 

Common Stock

 

 

Additional

 

 

 

 

 

 

Accumulated

other

 

 

Treasury Stock

 

 

Total

Athenex,

Inc.

 

 

Non-

 

 

Total

 

 

 

Shares

 

 

Amount

 

 

paid-in

capital

 

 

Accumulated

deficit

 

 

comprehensive

loss

 

 

Shares

 

 

Amount

 

 

stockholders'

equity

 

 

controlling

interests

 

 

stockholders'

equity

 

Balance at January 1, 2021

 

 

95,066,195

 

 

$

95

 

 

$

901,864

 

 

$

(713,644

)

 

$

(1,134

)

 

 

(1,672,920

)

 

$

(7,406

)

 

$

179,775

 

 

$

(14,427

)

 

$

165,348

 

Stock-based compensation cost

 

 

 

 

 

 

 

 

2,205

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,205

 

 

 

 

 

 

2,205

 

Restricted stock expense

 

 

 

 

 

 

 

 

29

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

29

 

 

 

 

 

 

29

 

Stock options exercised

 

 

119,425

 

 

 

 

 

 

852

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

852

 

 

 

 

 

 

852

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(25,050

)

 

 

 

 

 

 

 

 

 

 

 

(25,050

)

 

 

(553

)

 

 

(25,603

)

Other comprehensive income, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

293

 

 

 

 

 

 

 

 

 

293

 

 

 

 

 

 

293

 

Balance at March 31, 2021 (unaudited)

 

 

95,185,620

 

 

 

95

 

 

 

904,950

 

 

 

(738,694

)

 

 

(841

)

 

 

(1,672,920

)

 

 

(7,406

)

 

 

158,104

 

 

 

(14,980

)

 

 

143,124

 

Sale of common stock

 

 

33,373

 

 

 

 

 

 

133

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

133

 

 

 

 

 

 

133

 

Issuance of common stock in connection with acquisition of Kuur and settlement of transaction incentive liability assumed

 

 

15,601,667

 

 

 

16

 

 

 

58,412

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

58,428

 

 

 

 

 

 

58,428

 

Stock-based compensation cost

 

 

 

 

 

 

 

 

2,387

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,387

 

 

 

 

 

 

2,387

 

Restricted stock expense

 

 

 

 

 

 

 

 

57

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

57

 

 

 

 

 

 

57

 

Stock options exercised

 

 

160,000

 

 

 

 

 

 

727

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

727

 

 

 

 

 

 

727

 

Treasury stock repurchase

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(79

)

 

 

(79

)

 

 

 

 

 

(79

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(34,274

)

 

 

 

 

 

 

 

 

 

 

 

(34,274

)

 

 

(341

)

 

 

(34,615

)

Other comprehensive loss, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(282

)

 

 

 

 

 

 

 

 

(282

)

 

 

 

 

 

(282

)

Balance at June 30, 2021 (unaudited)

 

 

110,980,660

 

 

$

111

 

 

$

966,666

 

 

$

(772,968

)

 

$

(1,123

)

 

 

(1,672,920

)

 

$

(7,485

)

 

$

185,201

 

 

$

(15,321

)

 

$

169,880

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 

3


 

 

ATHENEX, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows

(unaudited)

(In thousands)

 

 

 

Six Months Ended June 30,

 

 

 

2021

 

 

2020

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(60,218

)

 

$

(60,769

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

2,467

 

 

 

2,121

 

Stock-based compensation expense

 

 

4,678

 

 

 

5,314

 

Amortization of debt discount

 

 

1,533

 

 

 

553

 

Change in fair value of contingent consideration

 

 

398

 

 

 

 

Write off of deferred debt issuance costs

 

 

648

 

 

 

 

Loss on disposal of assets and impairment charges

 

 

 

 

 

173

 

Loss on extinguishment of debt

 

 

 

 

 

7,230

 

Deferred income taxes

 

 

(10,940

)

 

 

51

 

Changes in operating assets and liabilities, net of effect of acquisition:

 

 

 

 

 

 

 

 

Receivables, net

 

 

1,385

 

 

 

(21,931

)

Prepaid expenses and other assets

 

 

(327

)

 

 

1,044

 

Inventories

 

 

(918

)

 

 

1,487

 

Accounts payable and accrued expenses

 

 

(7,796

)

 

 

(5,341

)

Net cash used in operating activities

 

 

(69,090

)

 

 

(70,068

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchase of property and equipment

 

 

(10,459

)

 

 

(4,566

)

Payments for licenses

 

 

(1,588

)

 

 

(83

)

Cash acquired from Kuur acquisition

 

 

1,425

 

 

 

 

Purchases of short-term investments

 

 

(67,600

)

 

 

(23,571

)

Sales and maturities of short-term investments

 

 

152,950

 

 

 

46,345

 

Net cash provided by investing activities

 

 

74,728

 

 

 

18,125

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Proceeds from sale of stock

 

 

133

 

 

 

269

 

Proceeds from issuance of debt

 

 

783

 

 

 

95,164

 

Proceeds from issuance of warrants

 

 

 

 

 

5,836

 

Costs incurred related to the issuance of debt and warrants

 

 

 

 

 

(6,125

)

Repurchase of treasury stock

 

 

(79

)

 

 

 

Proceeds from exercise of stock options

 

 

1,579

 

 

 

469

 

Investment from non-controlling interest

 

 

 

 

 

198

 

Repayment of finance lease obligations and long-term debt

 

 

(967

)

 

 

(54,238

)

Net cash provided by financing activities

 

 

1,449

 

 

 

41,573

 

Net increase (decrease) in cash, cash equivalents, and restricted cash

 

 

7,087

 

 

 

(10,370

)

Cash, cash equivalents, and restricted cash, beginning of period

 

 

86,087

 

 

 

127,674

 

Effect of exchange rate changes on cash, cash equivalents, and restricted cash

 

 

267

 

 

 

(403

)

Cash, cash equivalents, and restricted cash, end of period (See Note 3)

 

$

93,441

 

 

$

116,901

 

Supplemental cash flow disclosures

 

 

 

 

 

 

 

 

Interest paid

 

$

7,715

 

 

$

3,081

 

Non-cash investing and financing activities:

 

 

 

 

 

 

 

 

Accrued purchases of property and equipment

 

$

2,708

 

 

$

436

 

Accrued purchases of licenses

 

$

1,600

 

 

$

500

 

Stock issued in connection with the acquisition of Kuur

 

$

52,786

 

 

$

 

Fair value of acquisition-related contingent consideration

 

$

19,839

 

 

$

 

Equipment purchased with capital lease obligation

 

$

 

 

$

564

 

Accrued cost of debt issuance

 

$

 

 

$

287

 

ROU assets derecognized from modification of operating lease obligations

 

$

 

 

$

(468

)

ROU assets recognized in exchange for operating lease obligations

 

$

 

 

$

353

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

4


 

Athenex, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements (Unaudited)

1. Company and Nature of Business

Organization and Description of Business

Athenex, Inc. and subsidiaries (the “Company” or “Athenex”), originally under the name Kinex Pharmaceuticals LLC (“Kinex”), formed in November 2003, commenced operations on February 5, 2004, and operated as a limited liability company until it was incorporated in the State of Delaware under the name Kinex Pharmaceuticals, Inc. on December 31, 2012. The Company changed its name to Athenex, Inc. on August 26, 2015.

Athenex is a biopharmaceutical company dedicated to becoming a leader in the discovery, development, and commercialization of next generation drugs for the treatment of cancer. The Company’s mission is to improve the lives of cancer patients by creating more effective, safer and tolerable treatments. The Company has assembled a strong and experienced leadership team and has established operations across the pharmaceutical value chain to execute our goal of becoming a leader in bringing innovative cancer treatments to the market and improving health outcomes.

The Company is organized around three operating segments: (1) its Oncology Innovation Platform, dedicated to the research and development of our proprietary drugs; (2) its Commercial Platform, focused on the sales and marketing of our specialty drugs and the market development of our proprietary drugs; and (3) its Global Supply Chain Platform, dedicated to providing a stable and efficient supply of APIs for our clinical and commercial efforts. The Company’s current clinical pipeline in the Oncology Innovation Platform is derived from four different technologies: (1) Orascovery, based on a P-glycoprotein (“P-gp”) pump inhibitor, (2) Src Kinase Inhibition, (3) Cell Therapy, and (4) Arginine Deprivation Therapy.

The Company is primarily engaged in conducting research and development activities through corporate collaborators, in-licensing and out-licensing pharmaceutical compounds and technology, conducting preclinical and clinical testing, identifying and evaluating additional drug candidates for potential in-licensing or acquisition, and raising capital to support development and commercialization activities. The Company also conducts commercial sales of specialty products through its wholly owned subsidiary, Athenex Pharmaceutical Division (“APD”), and 503B products through its wholly owned subsidiary, Athenex Pharma Solutions (“APS”).                                 

Significant Risks and Uncertainties

The Company has incurred operating losses since its inception and, as a result, as of June 30, 2021 and December 31, 2020 had an accumulated deficit of $773.0 million and $713.6 million, respectively. As of June 30, 2021, the Company had cash and cash equivalents of $76.9 million, restricted cash of $16.5 million, and short-term investments of $53.3 million.

The Company believes that the existing cash and cash equivalents, restricted cash, and short-term investments will enable us to meet our current operational liquidity needs and fund operations through the fourth quarter of 2022. The Company has based these estimates on assumptions that may prove to be wrong, and it could spend the available financial resources much faster than expected and need to raise additional funds sooner than anticipated. Operations have been funded primarily through the sale of common stock, senior secured loans, and to a lesser extent, from convertible bond financing, revenue, and grant funding. The Company will require significant additional funds to conduct clinical trials and to fund its commercialization and manufacturing operations. There can be no assurance that this funding will be available for our use when needed, or at all. If adequate funds are not available, the Company may be required to delay, modify, or terminate its research and development programs or reduce its planned commercialization efforts. Further, if the Company is unable to obtain additional financing, the Company will need to reevaluate future operating plans. Although the Company plans to raise additional funds, these plans are subject to market conditions which are outside of its control and therefore cannot be deemed to be probable.

In February 2021, the Company received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the Company’s New Drug Application (“NDA”) for oral paclitaxel and encequidar (“Oral Paclitaxel”) for the treatment of metastatic breast cancer. The FDA issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form. In the CRL, the FDA indicated its concern of safety risk to patients in terms of an increase in neutropenia-related sequelae on the Oral Paclitaxel arm compared with the IV paclitaxel arm in the Phase III study. The FDA also expressed concerns regarding the uncertainty over the results of the primary endpoint of objective response rate (ORR) at week 19 conducted by blinded independent central review (“BICR”). The FDA stated that the BICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR. The FDA recommended that Athenex conduct a new adequate and well-conducted clinical trial in a patient population with metastatic breast cancer representative of the population in the U.S. The FDA determined that adequate risk mitigation strategies to improve toxicity, which may involve dose optimization as well as, or in addition to, exclusion of patients deemed to be at higher risk of toxicity, would be required in any new clinical trial of Oral Paclitaxel. During the second quarter of 2021, the Company held a Type A meeting with the FDA. At the meeting, the Company provided additional analyses,

5


 

including overall survival (OS) data on patient subgroups, to provide a more comprehensive summary of the risk/benefit assessment. The Company also proposed to collect additional OS data that could inform the design of a new clinical study. The Company is evaluating the optimal design for a new clinical study, which it intends to present to the FDA in the fourth quarter of 2021. The Company’s ability to potentially commercialize Oral Paclitaxel for the treatment of metastatic breast cancer, and the timing of such potential commercialization, is dependent on coming to an agreement with the FDA on the path forward for the program, the requirements and progress of a potential new clinical study, the Company’s resubmission of its NDA, ultimate FDA approval, and potentially additional capital.

The Company is subject to a number of risks similar to other biopharmaceutical companies, including, but not limited to, the lack of available capital; possible failure of preclinical testing or clinical trials; inability to obtain regulatory approval of product candidates; competitors developing new technological innovations; unsuccessful commercialization strategy and launch plans for its proprietary drug candidates; risks inherent in litigation, including purported class actions; market acceptance of the Company’s products; and protection of proprietary technology. If the Company or its partners do not successfully commercialize any of the Company’s product candidates, it will be unable to generate sufficient revenue and might not, if ever, achieve profitability and positive cash flow.            

2. Summary of Significant Accounting Policies

Basis of Presentation and Principles of Consolidation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles in the United States of America (“GAAP”) for interim financial information (Accounting Standards Codification (“ASC”) 270, Interim Reporting) and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, these financial statements do not include all of the information necessary for a full presentation of financial position, results of operations, and cash flows in conformity with GAAP. In the opinion of management, the condensed consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results of the Company for the periods presented. These condensed consolidated financial statements reflect the accounts and operations of Athenex, Inc. and those of its subsidiaries in which Athenex, Inc. has a controlling financial interest. Intercompany transactions and balances have been fully eliminated in consolidation.

Results of the Company’s operations for the three and six months ended June 30, 2021 are not necessarily indicative of the results expected for the year ending December 31, 2021, or for any other future annual or interim period. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission (“SEC”) on March 1, 2021.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and the reported amount of revenue and expenses during the reporting period. Such management estimates include those relating to assumptions used in clinical research accruals, chargebacks, measurement of acquired assets and assumed liabilities in business combinations, provision for credit losses, inventory reserves, deferred income taxes, the estimated useful life and recoverability of long-lived assets, and the valuation of stock-based awards and other items as appropriate. Actual results could differ from those estimates.

Credit Losses

The Company estimates and records a provision for its expected credit losses related to its financial instruments, including its trade receivables and contract assets recorded under Financial Accounting Standards Board (“FASB”) ASC 606, Revenue from Contracts with Customers (“Topic 606”). The Company considers historical collection rates, current financial status of its customers, macroeconomic factors, and other industry-specific factors when evaluating for current expected credit losses. Forward-looking information is also considered in the evaluation of current expected credit losses. However, because of the short time to the expected receipt of accounts receivable and contract assets, the Company believes that the carrying value, net of excepted losses, approximates fair value and therefore, relies more on historical and current analysis of such financial instruments.

6


 

Business Acquisitions

The Company accounts for acquired businesses using the acquisition method of accounting, which requires that assets acquired and liabilities assumed be recognized at their estimated fair values as of the acquisition date. Identifiable amortizing intangible assets are recorded on the consolidated balance sheet at fair value and amortized over their estimated useful lives. Acquisition-related costs are expensed as incurred. Any excess of the consideration transferred over the estimated fair values of the net assets acquired is recorded as goodwill. 

Contingent Consideration

Contingent consideration arising from a business acquisition is included as part of the purchase price and is recorded at fair value as of the acquisition date. Subsequent to the acquisition date, the Company remeasures contingent consideration arrangements at fair value at each reporting period until the contingency is resolved. The changes in fair value are recognized within selling, general, and administrative expenses in the Company’s consolidated statement of operations and comprehensive loss. Changes in fair values reflect new information about the likelihood of the payment of the contingent consideration and the passage of time.     

Concentration of Credit Risk, Other Risks and Uncertainties

Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents, restricted cash, and short-term investments. The Company deposits its cash equivalents in interest-bearing money market accounts and certificates of deposit, invests in highly liquid U.S. treasury notes, commercial paper, and corporate bonds. The Company deposits its cash with multiple financial institutions. Cash balances exceed federally insured limits. The primary focus of the Company’s investment strategy is to preserve capital and meet liquidity requirements. The Company’s investment policy addresses the level of credit exposure by limiting the concentration in any one corporate issuer and establishing a minimum allowable credit rating. The Company also has significant assets and liabilities held in its overseas manufacturing facility, and research and development facility in China, and therefore is subject to foreign currency fluctuation and regulatory uncertainties.

   

3. Restricted Cash

The Company had a restricted cash balance of $16.5 million as of June 30, 2021 and December 31, 2020 held in a controlled bank account in connection with the Company’s senior secured loan agreement and related security agreements (the “Senior Credit Agreement”) with Oaktree Fund Administration, LLC, as administrative agent, and the lenders party thereto (collectively, “Oaktree”). The Senior Credit Agreement requires the Company to maintain, in a debt service reserve account, a minimum cash balance equal to twelve months of interest on the outstanding loans under the Senior Credit Agreement.

4. Inventories

Inventories consist of the following (in thousands):

 

 

 

June 30,

2021

 

 

December 31,

2020

 

Raw materials and purchased parts

 

$

2,944

 

 

$

6,498

 

Work in progress

 

 

2,500

 

 

 

776

 

Finished goods

 

 

24,321

 

 

 

21,572

 

Total inventories

 

$

29,765

 

 

$

28,846

 

 

5. Business Combination

On May 4, 2021, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Kuur Therapeutics, Inc., a Delaware corporation (“Kuur”) whereby it acquired 100% of the outstanding shares of Kuur.  Under the terms of the Merger Agreement, the Company’s wholly owned subsidiary, Athenex Pharmaceuticals LLC, a Delaware limited liability company, merged with and into Kuur, with Kuur surviving as a wholly owned subsidiary of the Company. Kuur is a leading developer of off-the-shelf CAR-NKT cell immunotherapies for the treatment of solid and hematological malignancies. The Company believes the acquisition strategically combines its TCR program with the groundbreaking NKT cell platform to provide a solution that may address some of the known limitations associated with the first generation of cell therapy treatments focused on autologous CAR-T.

Pursuant to the Merger Agreement, an upfront fee of $70.0 million was paid to Kuur shareholders and its former employees and directors, comprised primarily of equity in the Company’s common stock. Additionally, Kuur shareholders and its former employees and directors are eligible to receive up to $115.0 million of milestone payments, which may be paid, at the Company’s sole discretion, in either cash or additional common stock of the Company (or a combination of both).

7


 

The Company identified the Merger as a business combination pursuant to ASC 805 and used the acquisition method of accounting to account for the transaction. The purchase price, after adjusted for closing conditions, consisted of 14,228,066 shares of the Company’s common stock issued at $3.71 per share with a fair value of $52.8 million, plus the fair value of the future milestone payments amounting to $19.8 million, recorded as contingent consideration. The Company recorded the fair value of this contingent consideration as a liability based on the probabilities of Kuur achieving the milestones and the present value of such payments. These inputs are not observable in in the market and therefore are considered Level 3 inputs.          

The Company estimated fair values on May 4, 2021 for the preliminary allocation of consideration to the net tangible and intangible assets acquired and liabilities assumed in connection with the Merger. During the measurement period, the Company will continue to obtain information to assist in finalizing the fair value of assets acquired and liabilities assumed, which may differ materially from these preliminary estimates. If any measurement period adjustments are material, those adjustments, including any related impacts to net income, will be applied in the reporting period in which the adjustments are determined. The Company is in the process of conducting a valuation of the assets acquired and liabilities assumed, most notably, the in-process research & development and contingent consideration, and the final allocation will be made when completed, including the result of any identified goodwill. Accordingly, the provisional measurements noted below are preliminary and subject to modification in the future. To estimate the preliminary fair value of the identifiable intangible assets acquired, the Company used projected discounted cash flow method, which requires assumptions of projected revenues and expenses and an estimated discount rate, among other inputs, each of which is not observable in the market and thus are considered Level 3 inputs. The Company assumed $8.9 million of transaction incentive liability to Kuur’s key employees and independent company directors, of which $3.3 million was paid in cash and $5.6 million was paid in 1,373,601 shares of the Company’s common stock at $4.11 per share.  The following table summarizes the purchase price and the initial estimates of the fair values of assets and liabilities acquired at the date of acquisition (in thousands):

 

Initial Allocation of Consideration:

 

 

 

 

Stock issued (14,228,066 shares at $3.71)

 

$

52,786

 

Contingent consideration

 

 

19,839

 

Purchase price:

 

$

72,625

 

Net assets acquired:

 

 

 

 

Cash and cash equivalents

 

$

1,425

 

Prepaid expenses and other current assets

 

 

133

 

In-process research & development

 

 

63,500

 

Accounts payable

 

 

(39

)

Accrued expenses

 

 

(1,037

)

Deferred income tax liability

 

 

(12,717

)

Transaction incentive liability

 

 

(8,925

)

Total identifiable net assets

 

 

42,340

 

Goodwill

 

 

30,285

 

Total purchase price allocation

 

$

72,625

 

 

Goodwill in the amount of $30.3 million was recorded for the excess of the purchase price over the fair value of the assets acquired and liabilities assumed. The goodwill recorded in connection with this acquisition is not deductible for income tax purposes. A deferred tax liability in the amount of $12.7 million was recorded related to the future taxable income as a result of the book to tax basis difference arising from the IPR&D.

The fair value of the acquired IPR&D relates to two products, including (a) an allogenic product in which NKT cells are engineered with a CAR targeting CD19, and (b) an allogenic product in which NKT cells are engineered with a CAR targeting GPC3. These IPR&D projects were valued using an income approach, specifically a projected discounted cash flow method, adjusted for the probability of technical success (PTS). The projected discounted cash flow models used to estimate the Company’s IPR&D reflect significant assumptions regarding the estimates a market participant would make in order to evaluate a drug development asset including the following:

 

Estimates of potential cash flows to be generated by the project and resulting asset, which was developed utilizing estimates of total patient population, market penetration rates, demand risk adjustment factors, and product pricing;

 

Estimates regarding the timing of and the expected cost of goods sold, research and development expenses, selling, general, and administrative expenses to advance the clinical programs to commercialization;

 

Estimates of profit sharing and cash flow adjustments;

8


 

 

 

The projected cash flows were then adjusted using PTS factors that were selected considering both the current state of development and the nature of the proposed indication; and

 

Finally, the resulting probability-adjusted cash flows were discounted to present value using a risk-adjusted discount rate, developed considering the market risk present in the forecast and the size of the asset.

This acquisition was made to benefit the Company’s R&D efforts, providing synergies with other assets in the Company’s pipeline and therefore, is included in the Oncology Innovation Platform. The operating results of Kuur have been included within the Company’s Oncology Innovation Platform operating segment from the date of acquisition. Kuur added revenue of $0 for the three months ended June 30, 2021 and contributed a net loss of $0.6 million for the three months ended June 30, 2021.

Acquisition-related costs, including legal, regulatory, and consulting costs, amounted to $3.5 million, and are included within selling, general, and administrative expenses in the Company’s consolidated statement of operations and comprehensive loss.

Unaudited Pro Forma Financial Results

The following table presents supplemental unaudited pro forma information for the acquisition as if it had occurred on January 1, 2020. The unaudited pro forma financial results for the three and six months ended June 30, 2021 include the following adjustments: (1) removal of direct acquisition-related costs which would not have been incurred had the businesses been owned on the beginning of the prior reporting period, (2) the deferred tax effect if the intangible assets and purchase accounting were recorded as of the beginning of the prior reporting period, and (3) the removal of the change in fair value of Kuur convertible debt which was converted prior to the consummation of the acquisition. The pro forma results do not include any anticipated synergies or other expected benefits of the acquisitions. The unaudited pro forma financial information is for informational purposes only and is not necessarily indicative of either future results of operations of the combined entity or results that might have been achieved had the acquisitions been consummated as of the beginning of the prior reporting period. The following table presents the unaudited pro forma consolidated financial information for the three and six months ended June 30, 2021 (in thousands):

 

Unaudited pro forma financial information

 

Three Months

Ended June 30,

 

 

Six Months

Ended June 30,

 

(Athenex and Kuur Consolidated)

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Consolidated revenue

 

$

21,923

 

 

$

40,172

 

 

$

62,948

 

 

$

88,157

 

Consolidated net loss

 

$

(31,261

)

 

$

(35,682

)

 

$

(58,197

)

 

$

(55,502

)

 

6. Intangible Assets, net

The Company’s identifiable intangible assets, net, consist of the following (in thousands):

 

 

 

June 30, 2021

 

 

 

Cost/Fair

Value

 

 

Accumulated

Amortization

 

 

Impairments

 

 

Net

 

Amortizable intangible assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Licenses

 

$

12,979

 

 

$

6,195

 

 

$

 

 

$

6,784

 

Polymed customer list

 

 

1,593

 

 

 

1,576

 

 

 

 

 

 

17

 

Polymed technology

 

 

3,712

 

 

 

1,804

 

 

 

 

 

 

1,908

 

Indefinite-lived intangible assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CDE in-process research and development (IPR&D)

 

 

728

 

 

 

 

 

 

 

 

 

728

 

Kuur IPR&D

 

 

63,500

 

 

 

 

 

 

 

 

 

63,500

 

Effect of currency translation adjustment

 

 

(158

)

 

 

 

 

 

 

 

 

(158

)

Total intangible assets, net

 

$

82,354

 

 

$

9,575

 

 

$

 

 

$

72,779

 

 

 

 

December 31, 2020

 

 

 

Cost/Fair

Value

 

 

Accumulated

Amortization

 

 

Impairments

 

 

Net

 

Amortizable intangible assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Licenses

 

$

12,641

 

 

$

5,157

 

 

$

 

 

$

7,484

 

Polymed customer list

 

 

1,593

 

 

 

1,418

 

 

 

 

 

 

175

 

Polymed technology

 

 

3,712

 

 

 

1,685

 

 

 

 

 

 

2,027

 

Indefinite-lived intangible assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CDE in-process research and development (IPR&D)

 

 

728

 

 

 

 

 

 

 

 

 

728

 

Effect of currency translation adjustment

 

 

(196

)

 

 

 

 

 

 

 

 

(196

)

Total intangibles, net

 

$

18,478

 

 

$

8,260

 

 

$

 

 

$

10,218

 

9


 

 

 

In connection with the acquisition of Kuur, the Company identified three drug candidate projects and two were classified as in-process research and development (“IPR&D”) and recorded at their fair value on the acquisition date. Included in the IPR&D is the historical know-how, cell treatment protocols, and procedures expected to be needed to complete the related phase of testing. The fair value of IPR&D was determined for each project, or unit of account, using unobservable, level 3 inputs (see Footnote 5 Business Combination). IPR&D intangible assets are not amortized, but rather are reviewed for impairment on an annual basis or more frequently if indicators of impairment are present, until the project is completed, abandoned, or transferred to a third party.

As of June 30, 2021, licenses at cost include an Orascovery license of $0.4 million, licenses purchased from Gland Pharma Limited (“Gland”) of $4.4 million, a license purchased from MAIA Pharmaceuticals, Inc. (“MAIA”) for $4.0 million, licenses purchased from Ingenus Pharmaceuticals, LLC (“Ingenus”) for $3.0 million, and licenses of other specialty products of $0.8 million. The Orascovery license with Hanmi Pharmaceuticals Co. Ltd. (“Hanmi”) was purchased directly from Hanmi and is being amortized on a straight-line basis over a period of 12.75 years, the remaining life of the license agreement at the time of purchase. The licenses purchased from Gland are being amortized on a straight-line basis over a period of 5 years, the remaining life of the license agreement at the time of purchase. The license purchased from MAIA is being amortized over a period of 7 years, the remaining life of the license agreement at the time of purchase. Of the $3.0 million licenses purchased from Ingenus, a $2.0 million license is being amortized over a period of 5 years, the estimated useful life of the license agreement and a $1.0 million license purchased from Ingenus is being amortized over a period of 3 years, the remaining life of the license agreement at the time of purchase.

The remaining intangible assets were acquired in connection with the acquisitions of Polymed Therapeutics, Inc. (“Polymed”) and Comprehensive Drug Enterprises (“CDE”). Intangible assets are amortized using an economic consumption model over their useful lives. The Polymed customer list and technology are amortized on a straight-line basis over 6 and 12 years, respectively. The CDE IPR&D will not be amortized until the related projects are completed. IPR&D is tested annually for impairment, unless conditions exist causing an earlier impairment test (e.g., abandonment of project). The Company recorded no impairment of IPR&D during the six months ended June 30, 2021. The weighted-average useful life for all intangible assets was 6.5 years as of June 30, 2021.

The Company recorded $0.5 million of amortization expense for each of the three-month periods ended June 30, 2021 and 2020, and $1.1 million and $0.9 million of amortization expense for the six-month periods ended June 30, 2021 and 2020, respectively.    

The Company’s goodwill balance is the result of current and prior period acquisitions and is allocated to the Global Supply Chain Platform reporting unit and the Oncology Innovation Platform reporting unit. Changes in goodwill balances reported within the unaudited condensed consolidated balance sheet as of June 30, 2021 are due to acquisition of Kuur on May 4, 2021, contributing goodwill of $30.3 million, and the effect of foreign currency on goodwill from acquisitions of subsidiaries that have a functional currency other than USD.

During the first quarter of 2021, due to the significant decrease in its market capitalization, the Company evaluated the impact on each of its reporting units to assess whether there was a triggering event requiring it to perform a goodwill impairment test (ASC350-20-35). The Company determined a triggering event occurred and, as such, performed an interim goodwill quantitative impairment test for its reporting units. It also considered certain qualitative factors, such as the Company’s performance, business forecasts, and expansion plans. It reviewed key assumptions, including revisions of projected cash flows and future revenue for reporting units against the results of the annual quantitative impairment test performed during the last quarter of 2020. Using both the income approach and the market approach for its Global Supply Chain Platform and Oncology Innovation Platform, with the discount rate selected considering and capturing the related risk associated with the forecast, the Company compared the fair value of the two reporting units to carrying value. Based on the results, the fair value of each of our reporting units exceeded their carrying value and the goodwill was not impaired. However, there can be no assurances that goodwill will not be impaired in future periods. Estimating the fair value of goodwill requires the use of estimates and significant judgments that are based on a number of factors. These estimates and judgments may not be within the control of the Company and accordingly it is reasonably possible that the judgments and estimates could change in future periods.  

7. Fair Value Measurements

Financial instruments consist of cash and cash equivalents, restricted cash, short-term investments, an available-for-sale equity investment, accounts receivable, accounts payable, accrued liabilities, contingent consideration, and debt. Short-term investments, the equity investment, and contingent consideration are stated at fair value. Cash and cash equivalents, restricted cash, accounts receivable, accounts payable and accrued liabilities, and debt, are stated at their carrying value, which approximates fair value due to the short time to the expected receipt or payment date of such amounts.

ASC 820, Fair Value Measurements, establishes a framework for measuring fair value. That framework provides a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to

10


 

unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurements) and the lowest priority to unobservable inputs (level 3 measurements). The three levels of the fair value hierarchy under the ASC 820 are described as follows:

Level 1—Inputs to the valuation methodology are unadjusted quoted prices for identical assets or liabilities in active markets that the Company has the ability to access.

Level 2—Inputs to the valuation methodology include:

 

Quoted prices for similar assets or liabilities in active markets;

 

Quoted prices for identical or similar assets or liabilities in inactive markets;

 

Inputs other than quoted prices that are observable for the asset or liability;

 

Inputs that are derived principally from or corroborated by observable market data by correlation or other means; and

 

If the asset or liability has a specified (contractual) term, the Level 2 input must be observable for substantially the full term of the asset or liability.

Level 3—Inputs to the valuation methodology are unobservable, supported by little or no market activity, and are significant to the fair value measurement.

Transfers between levels, if any, are recorded as of the beginning of the reporting period in which the transfer occurs. There were no transfers between Levels 1, 2 or 3 for any of the periods presented.

The following tables represent the fair value hierarchy for those assets and liabilities that the Company measures at fair value on a recurring basis (in thousands):

 

 

 

Fair Value Measurements at June 30, 2021 Using:

 

 

 

Total

 

 

Quoted Prices

in Active

Markets for

Identical Assets

(Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Financial assets included within cash and cash equivalents

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

19,711

 

 

$

19,711

 

 

$

 

 

$

 

Short-term investments - commercial paper

 

 

28,238

 

 

 

 

 

 

28,238

 

 

 

 

Financial assets included within short-term investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Short-term investments - certificates of deposit

 

 

22,773

 

 

 

 

 

 

22,773

 

 

 

 

Short-term investments - commercial paper

 

 

30,299

 

 

 

 

 

 

30,299

 

 

 

 

Available-for-sale investment

 

 

211

 

 

 

211

 

 

 

 

 

 

 

Total assets

 

$

101,232

 

 

$

19,922

 

 

$

81,310

 

 

$

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contingent consideration - Kuur

 

$

20,237

 

 

$

 

 

$

 

 

$

20,237

 

Total liabilities

 

$

20,237

 

 

$

 

 

$

 

 

$

20,237

 

11


 

 

 

 

 

Fair Value Measurements at December 31, 2020 Using:

 

 

 

Total

 

 

Quoted Prices

in Active

Markets for

Identical Assets

(Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Financial assets included within cash and cash equivalents

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

5,615

 

 

$

5,615

 

 

$

 

 

$

 

Short-term investments - certificates of deposit

 

 

4,070

 

 

 

 

 

 

4,070

 

 

 

 

Short-term investments - U.S. government bonds

 

 

5,000

 

 

 

 

 

 

5,000

 

 

 

 

Short-term investments - commercial paper

 

 

34,860

 

 

 

 

 

 

34,860

 

 

 

 

Financial assets included within short-term investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Short-term investments - certificates of deposit

 

 

20,696

 

 

 

 

 

 

20,696

 

 

 

 

Short-term investments - U.S. government bonds

 

 

14,998

 

 

 

 

 

 

14,998

 

 

 

 

Short-term investments - commercial paper

 

 

102,715

 

 

 

 

 

 

102,715

 

 

 

 

Available-for-sale investment

 

 

227

 

 

 

227

 

 

 

 

 

 

 

Total assets

 

$

188,181

 

 

$

5,842

 

 

$

182,339

 

 

$

 

 

The Company classifies its money market funds within Level 1 because it uses quoted market prices to determine their fair value. The Company classifies its commercial paper, corporate notes, certificates of deposit, and U.S. government bonds within Level 2 because it uses quoted prices for similar assets or liabilities in active markets and each has a specified term and all Level 2 inputs are observable for substantially the full term of each instrument.

The Company owns 68,000 shares of PharmaEssentia, a company publicly traded on the Taiwan OTC Exchange. As of June 30, 2021 and December 31, 2020, the Company’s investment in PharmaEssentia was valued at the reported closing price on such dates. This investment is classified as a Level 1 investment and is recorded as an available-for-sale investment within short-term investments on the Company’s condensed consolidated balance sheet.  

The Company accounted for the acquisition of Kuur as business combinations under the acquisition method of accounting. All assets and liabilities were measured at fair value as of the acquisition date. As a result of the purchases, the Company became liable for contingent consideration payable to certain previous owners of Kuur. This contingent consideration is measured at fair value using unobservable level 3 inputs, including (a) the estimated amount and timing of projected cash flows; (b) the probability of the achievement of the regulatory events on which the contingency is based; and (c) the risk-adjusted discount rate used to present value the probability-weighted cash flows. Significant increases (decreases) in any of those inputs could result in a lower or higher fair value measurement, and such changes in fair value measurement could have an impact on future earnings. The total undiscounted amount of the milestone payments underlying this liability is $115.0 million. These payments are contingent on the achievement of various regulatory milestones which are expected to occur between 2022 and 2027, and may be paid, at the Company’s sole discretion, in either cash or common stock (or a combination of both). The milestone payments have been adjusted based on a probability of occurrence of 28.3%, and the discount rates used to calculate the present value of future payments were based on risk-free rates plus risk-adjusted spreads based on the Company’s estimated incremental borrowing rate and was between 13.78% and 15.05% for the initial valuation of the contingent consideration. The acquisition of Kuur is described in Note 5—Business Combination and the fair value of the contingent consideration is discussed further in Note 11 – Contingent Consideration.

12


 

8. Accrued Expenses

Accrued expenses consist of the following (in thousands):

 

 

 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Accrued selling fees, rebates, and royalties

 

$

6,627

 

 

$

9,046

 

Accrued wages and benefits

 

 

6,447

 

 

 

6,720

 

Accrued interest

 

 

4,171

 

 

 

3,583

 

Accrued inventory purchases

 

 

3,805

 

 

 

3,714

 

Accrued construction costs

 

 

3,608

 

 

 

4,104

 

Accrued operating expenses

 

 

3,425

 

 

 

3,222

 

Accrued clinical expenses

 

 

2,293

 

 

 

2,949

 

Accrued R&D licensing fees

 

 

2,266

 

 

 

366

 

Accrued tax withholdings

 

 

1,546

 

 

 

1,948

 

Deferred revenue

 

 

1,082

 

 

 

1,147

 

Accrued costs for product launch

 

 

342

 

 

 

1,474

 

Total accrued expenses

 

$

35,612

 

 

$

38,273

 

 

The accrued construction costs relate to the building of the manufacturing facility in Dunkirk, NY. This amount, plus an additional $0.4 million paid by the Company is expected to be funded by New York State. Therefore, $4.0 million is recorded within prepaid expenses and other current assets on the Company’s condensed consolidated balance sheet as of June 30, 2021

9. Income Taxes

The Company did not record a provision for U.S. federal income taxes for the six months ended June 30, 2021 because it expects to generate a loss for the year ending December 31, 2021 and the Company’s net deferred tax assets continue to be fully offset by a valuation allowance. Income tax benefit to date is primarily the result of the taxable temporary difference due to the deferred tax liability recognized for the indefinite lived intangible assets acquired in connection with the acquisition of Kuur’s IPR&D. This taxable temporary difference is considered a source of taxable income to support the realization of deferred tax assets from the acquirer which resulted in a reversal of the Company’s valuation allowance.

Under the provisions of Section 382 of the Internal Revenue Code (“IRC”), net operating loss and credit carryforwards and other tax attributes may be subject to limitation if there has been a significant change in ownership of the Company, as defined by the IRC.   During the six months ended June 30, 2021, the Company experienced such a change in ownership of its common stock. Currently, the limitations imposed by Sections 382 are not expected to impair the Company’s ability to fully realize its NOLs; however, the annual usage of NOLs incurred prior to the change in ownership is limited. In addition, if the Company earns net taxable income in the future, its ability to use the pre-change net operating loss carryforwards to offset U.S. federal taxable income may be subject to limitations, which could potentially result in increased future tax liability to the Company.

10. Debt and Lease Obligations

Debt

The Company’s debt as of June 30, 2021 and December 31, 2020, consists of the following (in thousands):

 

 

 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Current portion of mortgage

 

$

740

 

 

$

731

 

Current portion of bank loan

 

 

772

 

 

 

764

 

Current portion of senior secured loan and financing fees

 

 

2,848

 

 

 

70

 

Current portion of finance lease obligations

 

 

365

 

 

 

445

 

Current portion of operating lease obligations

 

 

3,119

 

 

 

3,185

 

Long-term portion of finance lease obligations

 

 

424

 

 

 

537

 

Long-term portion of operating lease obligations

 

 

5,317

 

 

 

6,355

 

Chongqing Maliu credit agreement

 

 

7,728

 

 

 

7,641

 

Senior secured loan, net of debt discount and financing fees

   of $10,033 and $11,601 respectively

 

 

137,119

 

 

 

138,399

 

Total

 

$

158,432

 

 

$

158,127

 

 

13


 

 

Senior Credit Agreement

On June 19, 2020 (“Closing Date”), the Company entered into the Senior Credit Agreement with Oaktree to borrow up to $225.0 million in five tranches, with a maturity date of June 19, 2026. Three tranches (“Tranche A”, “Tranche B”, and “Tranche D”) of the term loans with an aggregate principal amount of $150.0 million were drawn by the Company in 2020. One tranche (“Tranche C”) of $25.0 million will be available to the Company from 90 days after the Closing Date through June 20, 2022, subject to the Company’s satisfaction of a certain regulatory milestone; and the last tranche of $50.0 million (“Tranche E”) will be available to the Company from 90 days after the Closing Date through June 19, 2023, also subject to the Company’s satisfaction of a certain commercial milestone. The loan bears interest at a fixed annual rate of 11.0%. The Company allocated the proceeds of the drawn tranches between liability and equity components and the fair value of such equity components, along with the direct costs related to the issuance of the debt were recorded as an offset to long-term debt on the consolidated balance sheets. The debt discount and financing fees are amortized on a straight-line basis, which approximates the effective interest method, over the remaining maturity of the Senior Credit Agreement. The effective interest rate of Tranches A, B and D, including the amortization of debt discount and financing fees amounts to 13.3% annually. The Company is required to make quarterly interest-only payments until June 19, 2022, after which the Company is required to make quarterly amortizing payments, with the remaining balance of the principal plus accrued and unpaid interest due at maturity. Beginning on September 17, 2020, the Company was required to pay a commitment fee on any undrawn commitments equal to 0.6% per annum, payable on each subsequent funding date or the commitment termination date. Prepayments of the loan, in whole or in part, will be subject to early prepayment fee which declines each year until the fourth anniversary date of the Closing Date, after which no prepayment fee is required. Upon the final payment, the Company must also pay an exit fee calculated based on a percentage of the aggregate principal amount of all tranches advanced to the Company, and as of June 30, 2021 and December 31, 2020, the Company has reflected a long-term exit fee liability of $3.0 million within long-term debt and finance lease obligations on the consolidated balance sheet.

The Senior Credit Agreement contains certain representations and warranties, affirmative covenants, negative covenants and conditions that were customarily required for similar financings. The Company is subject to certain financial covenants under the Senior Credit Agreement, including (1) a minimum liquidity amount in cash or permitted cash equivalent investments of $20.0 million from the closing date until the date on which the aggregate principal amount of loans outstanding is greater than or equal to $150.0 million (the “First Step-Up Date”), $25.0 million from the First Step-Up Date until the date on which the aggregate principal amount of loans outstanding balance is equal to $225.0 million (the “Second Step-Up Date”), and $30.0 million from the Second Step-up Date until the maturity date; (2) minimum revenue no less than 50% of target revenue beginning with the fiscal quarter ended on December 31, 2020 and with respect to each such subsequent fiscal quarter prior to the revenue covenant termination date; (3) leverage ratio covenant not to exceed 4.50 to 1.00 as of the last day of any fiscal quarter beginning with the first fiscal quarter following the revenue covenant termination date. At June 30, 2021, the Company was in compliance with all applicable debt covenants.

Revenue Interest Financing Agreement

On August 4, 2020, the Company entered into a Revenue Interest Financing Agreement with Sagard, pursuant to which Sagard agreed to pay the Company $50.0 million to provide funding for the Company’s development and commercialization of Oral Paclitaxel upon receipt of marketing authorization for Oral Paclitaxel by the U.S. FDA for the treatment of metastatic breast cancer. In the event the Company is unable to do so before December 31, 2021, Sagard will have a termination right. The Company believes that there is significant uncertainty that it will be able to obtain marketing authorization for Oral Paclitaxel by the U.S. FDA and draw funds from the Revenue Interest Financing, due to the receipt of the CRL and timing of the Type A meeting with the FDA. Therefore, the Company has written off its deferred debt issuance costs related to the Revenue Interest Financing for $0.6 million and has included such expense within interest expense on its condensed consolidated statement of operations and comprehensive loss for the three months ended June 30, 2021.

Credit Agreements, Bank Loan and Mortgage              

During the second quarter of 2019, the Company entered into a credit agreement which amended the existing partnership agreement with Chongqing Maliu Riverside Development and Investment Co., LTD (“CQ”), for a Renminbi ¥50.0 million (USD $7.7 million at December 31, 2020) line of credit to be used for the construction of the new API plant in China. The Company is required to repay the principal amount with accrued interest within three years after the plant receives the cGMP certification, with 20% of the total loan with accrued interest is due within the first twelve months following receiving the certification, 30% of the total loan with accrued interest due within twenty-four months, and the remaining balance with accrued interest due within thirty-six months. Interest accrues at the three-year loan interest rate by the People’s Bank of China for the same period on the date of the deposit of the full loan amount, which is expected to approximate 4.75% annually. If the Company fails to obtain the cGMP certification within three years upon the acceptance of the plant, it shall return all renovation costs with the accrued interest to CQ in a single transaction within the first ten business days. As of June 30, 2021, the balance due to CQ was $7.7 million.

14


 

On May 15, 2020, the Company entered into a credit agreement with China Merchants Bank, enabling the Company to draw up to a Renminbi ¥5.0 million (USD $0.8 million at June 30, 2021) during the period through May 14, 2021. The Company drew the entire available credit in July 2020 and repaid the credit agreement in full on May 14, 2021. On May 28, 2021, the Company entered into a credit agreement on the same terms as that which was repaid, and withdrew the full Renminbi ¥5.0 million (USD $0.8 million at June 30, 2021) on that date. This loan has a maturity date of May 28, 2022 and bears interest at a fixed rate of 4.35% annually. The Company is required to pay the outstanding principal and all accrued interest at maturity.

The mortgage payments, assumed in connection with the acquisition of CDE, extend through December 31, 2021.                

Lease Obligations

The Company has operating leases for office and manufacturing facilities in several locations in the U.S., Asia, and Latin America and has three finance leases for manufacturing equipment used in its facilities near Buffalo, NY. The components of lease expense are as follows (in thousands):

 

 

 

Three Months

Ended June 30,

 

 

Six Months

Ended June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Operating lease cost

 

 

747

 

 

$

768

 

 

 

1,494

 

 

$

1,523

 

Finance lease cost:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of assets

 

 

75

 

 

 

64

 

 

 

149

 

 

 

81

 

Interest on lease liabilities

 

 

22

 

 

 

20

 

 

 

46

 

 

 

26

 

Total net lease cost

 

$

844

 

 

$

852

 

 

$

1,689

 

 

$

1,630

 

 

The Company has elected to exclude short-term leases from its operating lease right-of-use (“ROU”) assets and lease liabilities. Lease costs for short-term leases were not material to the financial statements for the three months ended June 30, 2021 and 2020. Variable lease costs for the three months ended June 30, 2021 were not material to the financial statements.

Supplemental balance sheet information related to leases is as follows (in thousands, except lease term and discount rate):

 

 

 

June 30, 2021

 

 

December 31, 2020

 

Finance leases:

 

 

 

 

 

 

 

 

Property and equipment, at cost

 

$

1,535

 

 

$

1,535

 

Accumulated amortization, net

 

 

(497

)

 

 

(347

)

Property and equipment, net

 

$

1,038

 

 

$

1,188

 

 

 

 

 

 

 

 

 

 

Current obligations of finance leases

 

$

365

 

 

$

445

 

Long-term portion of finance leases

 

 

424

 

 

 

537

 

Total finance lease obligations

 

$

789

 

 

$

982

 

 

 

 

 

 

 

 

 

 

Weighted average remaining lease term (in years):

 

 

 

 

 

 

 

 

Operating leases

 

 

3.81

 

 

 

4.23

 

Finance leases

 

 

2.84

 

 

 

3.40

 

 

 

 

 

 

 

 

 

 

Weighted average discount rate:

 

 

 

 

 

 

 

 

Operating leases

 

 

12.8

%

 

 

12.8

%

Finance leases

 

 

10.8

%

 

 

10.4

%

 

15


 

 

Supplemental cash flow information related to leases is as follows (in thousands):

 

 

 

Six

Months Ended

June 30, 2021

 

 

Six

Months Ended

June 30, 2020

 

Cash paid for amount included in the measurements of lease liabilities:

 

 

 

 

 

 

 

 

Operating cash flows from operating leases

 

$

(1,696

)

 

$

(1,617

)

Operating cash flows from finance leases

 

 

(22

)

 

 

(26

)

Financing cash flows from finance leases

 

 

(192

)

 

 

(118

)

 

 

 

 

 

 

 

 

 

ROU assets derecognized from modification of operating lease

   obligations

 

 

 

 

 

(468

)

ROU assets recognized in exchange for operating lease

   obligations

 

$

 

 

$

353

 

 

Future minimum payments and maturities of leases is as follows (in thousands):

 

Year ending December 31:

 

Operating Leases

 

Finance Leases

 

2021 (remaining six months)

 

$

1,716

 

$

234

 

2022

 

 

2,929

 

 

275

 

2023

 

 

2,096

 

 

248

 

2024

 

 

2,002

 

 

177

 

2025

 

 

1,472

 

 

 

Thereafter

 

 

478

 

 

 

Total lease payments

 

 

10,693

 

 

934

 

Less: Imputed interest

 

 

(2,257

)

 

(145

)

Total lease obligations

 

 

8,436

 

 

789

 

Less: Current obligations

 

 

(3,119

)

 

(365

)

Long-term lease obligations

 

$

5,317

 

$

424

 

 

Pursuant to the public-private partnership agreements with the State of New York, the Company will rent the manufacturing facilities in Dunkirk, NY. The facility is in the final stage of completion. However, no lease term had commenced as of June 30, 2021, as it was not yet operational and the Company could not direct the use of the facility. No lease costs were incurred related to the manufacturing facility during the three-month period ended June 30, 2021.

On January 5, 2021, Chongqing Sintaho Pharmaceuticals Co., Ltd. (“CQ Sintaho”), a subsidiary of the Company in China, entered into a lease agreement with Chongqing International Biological City Development & Investment Co., Ltd (“CQ D&I”). Under the lease agreement, the provisions of which are consistent with those agreed upon in the 2015 Agreement, CQ Sintaho leased the newly constructed API facility, or Sintaho API Facility, of 34,517 square meters rent-free, for the first 10-year term, with an option to extend the lease for an additional 10-year term, during which, if CQ Sintaho is profitable, it will pay a monthly rent of 5 RMB per square meter of space occupied. The Company determined the lease commenced in the first quarter of 2021, as it was operational and CQ Sintaho could direct the use of the facility. The Company also evaluated the probability of exercising the renewal and purchase options, and determined that it is not reasonably certain whether it will exercise those options. Therefore, the lease term is comprised only of the rent-free period and the recognition of the right-of-use asset and liability did not have a significant effect on the Company’s consolidated financial statements.

The Company exercises judgment in determining the discount rate used to measure the lease liabilities. When rates are not implicit within an operating lease, the Company uses its incremental borrowing rate as its discount rate, which is based on yield trends in the biotechnology and healthcare industry and debt instruments held by the Company with stated interest rates. The Company re-assesses its incremental borrowing rate when new leases arise, or existing leases are modified.

16


 

11. Contingent Consideration

The fair value measurements of contingent consideration liabilities are determined using unobservable Level 3 inputs. These inputs include (a) the estimated amount and timing of projected cash flows; (b) the probability of the achievement of the factors on which the contingency is based; and (c) the risk-adjusted discount rate used to present value the probability-weighted cash flows. Significant increases (decreases) in any of those inputs could result in a lower or higher fair value measurement. The Company expects that these milestones will be achieved at varying times between 2022 and 2027.

The following table represents a reconciliation of the contingent consideration liability related to the acquisition of Kuur measured on a recurring basis using level 3 inputs as of June 30, 2021 (in thousands):

 

Balance as of May 4, 2021

 

$

19,839

 

Adjustment to fair value

 

 

398

 

Balance as of June 30, 2021

 

$

20,237

 

 

The increase of the contingent consideration was due to the time value of money from the initial measurement date (Kuur acquisition date) to June 30, 2021, as well as updated probabilities of future cash flows related to R&D milestones. The adjustment to the contingent consideration liability is included within selling, general, and administrative expenses in the Company’s condensed consolidated statements of operations and comprehensive loss.

12. Related Party Transactions

During the six months ended June 30, 2021 and 2020, the Company entered into transactions with individuals and companies that have financial interests in the Company. Related party transactions included the following:

a.

In June 2018, the Company entered into two in-licensing agreements with Avalon BioMedical (Management) Limited (“Avalon”) wherein the Company obtained certain IP from Avalon to develop and commercialize the underlying products. Under these agreements the Company is required to pay upfront fees and future milestone payments and sales-based royalties. During the three and six months ended June 30, 2021 and 2020, no fees were paid to Avalon in connection with the license agreements. Certain members of the Company’s board and management collectively have a controlling interest in Avalon. The Company does not hold any interest in Avalon and does not have any obligations to absorb losses or any rights to receive benefits from Avalon. As of June 30, 2021, and December 31, 2020, Avalon held 786,061 shares of the Company’s common stock, which represented approximately 1% of the Company’s total issued shares for both periods. Balances due from Avalon recorded on the condensed consolidated balance sheets were not significant. In July 2021, the Company made $2.0 million milestone payment to Avalon pursuant to its license agreement.

In June 2019, the Company entered into an agreement whereby Avalon would hold a 90% ownership interest and the Company would hold a 10% ownership interest of the newly formed entity under the name Nuwagen Limited (“Nuwagen”), incorporated under the laws of Hong Kong. Nuwagen is principally engaged in the development and commercialization of herbal medicine products for metabolic, endocrine, and other related indications. The Company contributed nonmonetary assets in exchange for the 10% ownership interest. In July 2020, the transaction closed. The activities of Nuwagen were not material to the financial statements for the three or six months ended June 30, 2021.

b.

The Company earns licensing revenue from PharmaEssentia, an entity in which the Company has an investment classified as available-for-sale (see Note 7—Fair Value Measurements). During the three and six months ended June 30, 2021, the Company recorded $0 and $0.5 million milestone fee earned from PharmaEssentia under a license agreement, respectively. There were no funds paid to PharmaEssentia under the cost-sharing agreements for the three and six months ended June 30, 2021 and 2020.   

In September 2020, Axis Therapeutics Limited (“Axis”), a majority-owned subsidiary of the Company, entered into a collaboration agreement with PharmaEssentia, pursuant to which Axis granted to PharmaEssensia an exclusive, non-transferrable and revocable sublicense of TCR-engineered T-Cell therapy for the development of the technology in Taiwan. Axis received license fee of $1.0 million, net of $0.3 million withholding tax, in the fourth quarter of 2020. This amount was recorded as deferred revenue as of June 30, 2021.        

c.

The Company receives certain clinical development services from ZenRx Limited and its affiliate (collectively, “ZenRx”), a company for which one of the Company’s executive officers serves on the board of directors. In connection with such services, the Company made payments to ZenRx of less than $0.1 million and $0.2 million for the three months ended June 30, 2021 and 2020, respectively, and the Company made payments to ZenRx of $0.3 million for each of the six months ended June 30, 2021 and 2020. In April 2013, the Company entered into a license agreement with ZenRx pursuant to which the Company granted an exclusive, sublicensable license to use certain of the Company’s IP to develop and commercialize oral irinotecan and encequidar (“Oral Irinotecan”), and Oral Paclitaxel in Australia and New Zealand, and a non-exclusive license to manufacture a certain

17


 

compound, but only for use in Oral Irinotecan and Oral Paclitaxel. ZenRx is responsible for all development, manufacturing and commercialization, and the related costs and expenses, of any product candidates resulting from the agreement. No revenue was earned from this license agreement in the periods presented in these consolidated financial statements.          

d.

Certain directors and family members of executives perform consulting services for the Company. Such services were not significant to the condensed consolidated financial statements.

13. Stock-Based Compensation

Common Stock Option Plans

The Company has four equity compensation plans, adopted in 2017, 2013, 2007 and 2004 (the “Plans”) which, taken together, authorize the grant of up to 16,000,000 shares of common stock to employees, directors, and consultants. On May 23, 2019, the board of directors approved the amendment and restatement of the 2017 Omnibus Incentive Plan (the “2017 Plan”, which increases the number of shares available for issuance under the 2017 Plan by up to 3,500,000 shares, which was approved by the Company’s stockholders at the Company’s 2020 annual meeting of stockholders. On April 26, 2021, the board of directors approved an amendment to the 2017 Plan, which increases the number of shares available for issuance under the 2017 Plan by 5,000,000 shares, which was approved by the Company’s stockholders at the Company’s 2021 annual meeting of stockholders. The Company also has an employee stock purchase plan, the 2017 Employee Stock Purchase Plan (the “ESPP”), adopted on June 14, 2017, which authorizes the issuance of up to 1,000,000 shares of common stock for future issuances to eligible employees.  

Stock Options

The total fair value of stock options vested and recorded as compensation expense during the three months ended June 30, 2021 and 2020, and six months ended June 30, 2021 and 2020 was $2.3 million, $2.5 million, $4.5 million, and $4.4 million, respectively. As of June 30, 2021, $14.2 million of unrecognized cost related to non-vested stock options was expected to be recognized over a weighted-average period of approximately 1.7 years. The total intrinsic value of options exercised was approximately $0.2 million and $0.8 million for the six months ended June 30, 2021 and 2020, respectively.

The following table summarizes the status of the Company’s stock option activity granted under the Plans to employees, directors, and consultants (aggregate intrinsic value in thousands):

 

 

 

Stock

Options

 

 

Weighted-

Average

Exercise price

 

 

Weighted-

Average

Remaining

Contractual

Term

 

 

Aggregate

Intrinsic Value

 

Outstanding at December 31, 2020

 

 

12,496,888

 

 

$

9.26

 

 

 

5.42

 

 

$

22,463

 

Granted

 

 

28,500

 

 

 

9.75

 

 

 

 

 

 

 

Exercised

 

 

(279,425

)

 

 

5.64

 

 

 

 

 

 

 

Forfeited and expired

 

 

(219,365

)

 

 

8.33

 

 

 

 

 

 

 

Outstanding at June 30, 2021

 

 

12,026,598

 

 

$

9.39

 

 

 

5.07

 

 

$

 

Vested and exercisable at June 30, 2021

 

 

9,426,192

 

 

$

8.40

 

 

 

4.21

 

 

$

 

 

The Company determines the fair value of stock-based awards on the grant date using the Black-Scholes option pricing model, which is impacted by assumptions regarding several highly subjective variables. The following table summarizes the weighted-average assumptions used as inputs to the Black-Scholes model during the periods indicated:

 

 

 

Six Months

Ended June 30,

 

 

 

2021

 

 

2020

 

Weighted average grant date fair value

 

$

6.18

 

 

$

7.60

 

Expected dividend yield

 

 

%

 

 

%

Expected stock price volatility

 

 

68

%

 

 

66

%

Risk-free interest rate

 

 

1.45

%

 

 

1.34

%

Expected life of options (in years)

 

 

6.3

 

 

 

6.2

 

 

   

Restricted Stock Awards  

The Company granted 48,000 restricted stock units during the three months ended June 30, 2021. No restricted stock awards were granted during the three or six months ended June 30, 2020. Stock-based compensation related to the restricted stock awards

18


 

amounted to $0.1 million and $0.4 million for the three months ended June 30, 2021 and 2020, respectively, and $0.1 million and $0.8 million for the six months ended June 30, 2021 and 2020, respectively. As of June 30, 2021, $0.5 million of unrecognized cost related to non-vested restricted stock awards were expected to be recognized over a weighted-average period of approximately 0.7 years.   

Employee Stock Purchase Plan

The ESPP is available to eligible employees (as defined in the plan document). Under the ESPP, shares of the Company’s common stock may be purchased at a discount (15%) of the lesser of the closing price of the Company’s common stock on the first trading or the last trading day of the offering period. The current offering period extends from June 1, 2021 to November 30, 2021. The Company expects to offer six-month offering periods after the current period. The ESPP reserved 1,000,000 shares of common stock for issuance under the ESPP. Stock-based compensation related to the ESPP amounted to less than $0.1 million and $0.1 million for each of the three months ended June 30, 2021 and 2020, respectively, and $0.1 million for each of the six months ended June 30, 2021 and 2020, respectively.   

Stock-Based Compensation Cost

The components of stock-based compensation and the amounts recorded within cost of sales, research and development expenses and selling, general, and administrative expenses in the Company’s consolidated statements of operations and comprehensive loss consisted of the following for the three and six months ended June 30, 2021 and 2020 (in thousands):

 

 

 

Three Months

Ended June 30,

 

 

Six Months

Ended June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Stock options

 

$

2,341

 

 

$

2,501

 

 

$

4,500

 

 

$

4,365

 

Restricted stock expense

 

 

57

 

 

 

413

 

 

 

86

 

 

 

810

 

Employee stock purchase plan

 

 

46

 

 

 

139

 

 

 

92

 

 

 

139

 

Total stock-based compensation expense

 

$

2,444

 

 

$

3,053

 

 

$

4,678

 

 

$

5,314

 

Cost of sales

 

$

59

 

 

$

55

 

 

$

115

 

 

$

109

 

Research and development expenses

 

 

671

 

 

 

1,012

 

 

 

1,272

 

 

 

1,958

 

Selling, general, and administrative expenses

 

 

1,714

 

 

 

1,986

 

 

 

3,291

 

 

 

3,247

 

Total stock-based compensation expense

 

$

2,444

 

 

$

3,053

 

 

$

4,678

 

 

$

5,314

 

 

14. Net Loss per Share Attributable to Athenex, Inc. Common Stockholders

Basic net loss per share is calculated by dividing net loss attributable to Athenex, Inc. common stockholders by the weighted-average number of common shares issued, outstanding, and vested during the period. Diluted net loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common stock and common stock equivalents for the period using the treasury-stock method. For the purposes of this calculation, warrants to purchase common stock and stock options are considered common stock equivalents but are only included in the calculation of diluted net loss per share when their effect is dilutive.

The following outstanding shares of common stock equivalents were excluded from the calculation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive:

 

 

 

Three Months

Ended June 30,

 

 

Six Months

Ended June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Stock options and other common stock equivalents

 

 

13,568,672

 

 

 

11,700,399

 

 

 

13,560,708

 

 

 

11,709,928

 

Unvested restricted shares

 

 

52,566

 

 

 

79,000

 

 

 

37,616

 

 

 

105,000

 

Total potential dilutive shares

 

 

13,621,238

 

 

 

11,779,399

 

 

 

13,598,324

 

 

 

11,814,928

 

 

15. Business Segment, Geographic, and Concentration Risk Information

The Company has three operating segments, which are organized based mainly on the nature of the business activities performed and regulatory environments in which they operate. The Company also considers the types of products from which the reportable segments derive their revenue (only applicable to two reportable segments). Each operating segment has a segment manager who is held accountable for operations and has discrete financial information that is regularly reviewed by the Company’s chief operating decision-maker. Consequently, the Company has concluded each operating segment to be a reportable segment. The Company’s operating segments are as follows:   

19


 

Oncology Innovation Platform— This operating segment performs research and development on certain of the Company’s proprietary drugs, from the preclinical development of its chemical compounds, to the execution and analysis of its several clinical trials. It focuses specifically on cell therapy programs, Orascovery and Src Kinase Inhibition research platforms, and arginine deprivation therapy.

Global Supply Chain Platform— This operating segment includes APS and Polymed and the construction of the manufacturing facilities in Chongqing, China, and Dunkirk, NY. APS is a manufacturing company that supplies sterile injectable drugs to hospital pharmacies across the U.S. APS manufactures products under Section 503B of the Compounding Quality Act within the Federal Food, Drug & Cosmetic Act (“FDCA”). Additionally, APS provides products for the development and manufacturing of the Company’s proprietary drug candidates as well as providing the Company with a cGMP analytical services function. Polymed is primarily in the business of marketing and selling API in North America, Europe, and Asia from its locations in Texas and China. Polymed also develops new compounds and processing techniques and is in the final phase of completion of the new API manufacturing facility in Chongqing, China. 

Commercial Platform— This operating segment includes APD, which focuses on the manufacturing, distribution, and sales of specialty pharmaceuticals and Athenex Oncology, which focus on the manufacturing, distribution, and sales of specialty pharmaceuticals and the pre-launch commercial activities for the Company’s proprietary drugs, respectively. This segment provides services and products to external customers based mainly in the U.S.

The Company’s Oncology Innovation Platform segment operates and holds long-lived assets located in the U.S., Taiwan, Hong Kong, mainland China, the United Kingdom, and Latin America. The Global Supply Chain Platform segment operates and holds long-lived assets located in the U.S. and China. The Commercial Platform segment operates and holds long-lived assets located in the U.S. For geographic segment reporting, product sales have been attributed to countries based on the location of the customer.  

Segment information is as follows (in thousands):

 

 

 

Three Months

Ended June 30,

 

 

Six Months

Ended June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Total revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Oncology Innovation Platform

 

$

306

 

 

$

5

 

 

$

20,971

 

 

$

28,393

 

Global Supply Chain Platform

 

 

6,112

 

 

 

4,982

 

 

 

14,319

 

 

 

8,696

 

Commercial Platform

 

 

15,791

 

 

 

36,214

 

 

 

29,050

 

 

 

51,755

 

Total revenue for reportable segments

 

 

22,209

 

 

 

41,201

 

 

 

64,340

 

 

 

88,844

 

Intersegment revenue

 

 

(286

)

 

 

(1,029

)

 

 

(1,392

)

 

 

(1,737

)

Total consolidated revenue

 

$

21,923

 

 

$

40,172

 

 

$

62,948

 

 

$

87,107

 

 

Intersegment revenue eliminated in the above table reflects $0.3 million and $0.8 million in sales from the Global Supply Chain Platform to the Oncology Innovation Platform for the three and six months ended June 30, 2021, respectively, and $1.0 million and $1.7 million for the three and six months ended June 30, 2020, respectively. Intersegment revenue eliminated in the above table also reflects $0.6 million in sales from the Global Supply Chain Platform to the Commercial Platform for the six months ended June 30, 2021.           

 

 

 

Three Months

Ended June 30,

 

 

Six Months

Ended June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Total revenue by product group:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

License fees

 

$

296

 

 

$

 

 

$

20,953

 

 

$

28,381

 

Commercial product sales

 

 

19,970

 

 

 

38,881

 

 

 

38,033

 

 

 

56,383

 

API sales

 

 

986

 

 

 

1,229

 

 

 

2,854

 

 

 

2,251

 

Contract manufacturing revenue

 

 

427

 

 

 

57

 

 

 

857

 

 

 

80

 

Other revenue

 

 

244

 

 

 

5

 

 

 

251

 

 

 

12

 

Total consolidated revenue

 

$

21,923

 

 

$

40,172

 

 

$

62,948

 

 

$

87,107

 

 

20


 

 

Intersegment revenue is recognized by the selling segment when its customer obtains control of promised goods or services, in an amount that reflects the consideration which it expects to receive in exchange for those goods or services. Upon consolidation, all intersegment revenue and related cost of sales are eliminated from the selling segment’s ledger (in thousands).

 

 

 

Three Months

Ended June 30,

 

 

Six Months

Ended June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Net loss attributable to Athenex, Inc.:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Oncology Innovation Platform

 

$

(20,122

)

 

$

(35,024

)

 

$

(25,563

)

 

$

(35,982

)

Global Supply Chain Platform

 

 

(3,944

)

 

 

(5,745

)

 

 

(7,626

)

 

 

(11,731

)

Commercial Platform

 

 

(10,208

)

 

 

318

 

 

 

(26,135

)

 

 

(12,167

)

Total consolidated net loss attributable to

   Athenex, Inc.

 

$

(34,274

)

 

$

(40,451

)

 

$

(59,324

)

 

$

(59,880

)

 

 

 

Three Months

Ended June 30,

 

 

Six Months

Ended June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Total depreciation and amortization:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Oncology Innovation Platform

 

$

224

 

 

$

188

 

 

$

438

 

 

$

363

 

Global Supply Chain Platform

 

 

508

 

 

 

426

 

 

 

1,023

 

 

 

922

 

Commercial Platform

 

 

461

 

 

 

421

 

 

 

1,006

 

 

 

836

 

Total consolidated depreciation and

   amortization

 

$

1,193

 

 

$

1,035

 

 

$

2,467

 

 

$

2,121

 

 

 

 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Total assets:

 

 

 

 

 

 

 

 

Oncology Innovation Platform

 

$

246,252

 

 

$

234,153

 

Global Supply Chain Platform

 

 

107,647

 

 

 

99,087

 

Commercial Platform

 

 

55,058

 

 

 

51,089

 

Total consolidated assets

 

$

408,957

 

 

$

384,329

 

 

 

 

Three Months

Ended June 30,

 

 

Six Months

Ended June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Total revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

United States

 

$

20,679

 

 

$

26,001

 

 

$

59,323

 

 

$

43,522

 

China

 

 

652

 

 

 

125

 

 

 

858

 

 

 

28,638

 

South Korea

 

 

445

 

 

 

1,060

 

 

 

1,112

 

 

 

1,693

 

India

 

 

 

 

 

 

 

 

906

 

 

 

 

United Kingdom

 

 

 

 

 

12,933

 

 

 

 

 

 

12,933

 

Other foreign countries

 

 

147

 

 

 

53

 

 

 

749

 

 

 

321

 

Total consolidated revenue

 

$

21,923

 

 

$

40,172

 

 

$

62,948

 

 

$

87,107

 

 

 

 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Total property and equipment, net:

 

 

 

 

 

 

 

 

United States

 

$

22,395

 

 

$

15,511

 

China

 

 

23,290

 

 

 

18,877

 

Total consolidated property and equipment, net

 

$

45,685

 

 

$

34,388

 

 

21


 

 

Customer revenue and accounts receivable concentration amounted to the following for the identified periods. These customers relate to the Commercial Platform segment and the Global Supply Chain Platform segment.

 

 

 

Three Months

Ended June 30,

 

 

Six Months

Ended June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Percentage of total revenue by customer:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Customer A

 

 

22

%

 

 

14

%

 

 

15

%

 

 

6

%

Customer B

 

 

21

%

 

 

15

%

 

 

13

%

 

 

7

%

Customer C

 

 

19

%

 

 

9

%

 

 

12

%

 

 

4

%

Customer D

 

 

0

%

 

 

0

%

 

 

32

%

 

 

0

%

Customer E

 

 

0

%

 

 

32

%

 

 

0

%

 

 

15

%

Customer F

 

 

0

%

 

 

0

%

 

 

0

%

 

 

32

%

 

 

 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Percentage of total accounts receivable by customer:

 

 

 

 

 

 

 

 

Customer A

 

 

35

%

 

 

33

%

Customer B

 

 

30

%

 

 

24

%

Customer C

 

 

17

%

 

 

16

%

Customer D

 

 

0

%

 

 

6

%

 

16. Revenue Recognition

The Company records revenue in accordance with ASC, Topic 606 “Revenue from Contracts with Customers.” Under Topic 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which it expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of Topic 606, the entity performs the following five steps: (i) identifies the contract(s) with a customer; (ii) identifies the performance obligations in the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. Below is a description of principal activities – separated by reportable segments – from which the Company generates its revenue.

 

1.

Oncology Innovation Platform

The Company out-licenses certain of its IP to other pharmaceutical companies in specific territories that allow the customer to use, develop, commercialize, or otherwise exploit the licensed IP. In accordance with Topic 606, the Company analyzes the contracts to identify its performance obligations within the contract. Most of the Company’s out-license arrangements contain multiple performance obligations and variable pricing. After the performance obligations are identified, the Company determines the transaction price, which generally includes upfront fees, milestone payments related to the achievement of developmental, regulatory, or commercial goals, and royalty payments on net sales of licensed products. The Company considers whether the transaction price is fixed or variable, and whether such consideration is subject to return. Variable consideration is only included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. If any portion of the transaction price is constrained, it is excluded from the transaction price until the constraint no longer exists. The Company then allocates the transaction price to the performance obligation to which the consideration is related. Where a portion of the transaction price is received and allocated to continuing performance obligations under the terms of the arrangement, it is recorded as deferred revenue and recognized as revenue when (or as) the underlying performance obligation is satisfied.

The Company’s contracts may contain one or multiple promises, including the license of IP and development services. The licensed IP is capable of being distinct from the other performance obligations identified in the contract and is distinct within the context of the contract, as upon transfer of the IP, the customer is able to use and benefit from it, and the customer could obtain the development services from other parties. The Company also considers the economic and regulatory characteristics of the licensed IP and other promises in the contract to determine if it is a distinct performance obligation. The Company considers if the IP is modified or enhanced by other performance obligations through the life of the agreement and whether the customer is contractually or practically required to use updated IP. The IP licensed by the Company has been determined to be functional IP. The IP is not modified during the license period and therefore, the Company recognizes revenues from any portion of the transaction price allocated to the licensed IP when the license is transferred to the customer and they can benefit from the right to use the IP. For the three and six month period ended June 30, 2021, the Company recognized license revenue of $0.2 million and $20.8 million, respectively, of which $20.0 million was recognized upon the achievement of the first commercial milestone pursuant to the 2017 Almirall out-license

22


 

arrangement upon the launch of Klisyri® (tirbanibulin) in the U.S., and $0.5 million was recognized for an upfront fee upon transferring IP to the customer upon execution of the second amendment to the 2011 PharmaEssentia license agreement. For the six-month period ended June 30, 2020, the Company recognized revenue of $28.3 million, net of $1.7 million value added tax (“VAT”) collected on behalf of the counterparty, upon transferring certain IP to the customer. No license revenue was recognized for the three-month period ended June 30, 2020. During the fourth quarter of 2020 and under the collaboration agreement between Axis Therapeutics and PharmaEssentia, the Company received $1.0 million, net of $0.3 million withholding tax, of upfront fees allocated to its performance obligation to deliver functional IP to the Customer. As of June 30, 2021, the Company had not satisfied this performance obligation by delivering the license with the data necessary for the customer to benefit from the right to use the IP and, therefore, the amount was recorded as deferred revenue.

Other performance obligations included in most of the Company’s out-licensing agreements include performing development services to reach clinical and regulatory milestone events. The Company satisfies these performance obligations at a point-in-time, because the customer does not simultaneously receive and consume the benefits as the development occurs, the development does not create or enhance an asset controlled by the customer, and the development does not create an asset with no alternative use. The Company considers milestone payments to be variable consideration measured using the most likely amount method, as the entitlement to the consideration is contingent on the occurrence or nonoccurrence of future events. The Company allocates each variable milestone payment to the associated milestone performance obligation, as the variable payment relates directly to the Company’s efforts to satisfy the performance obligation and such allocation depicts the amount of consideration to which the Company expects to be entitled for satisfying the corresponding performance obligation. The Company re-evaluates the probability of achievement of such performance obligations and any related constraint and adjusts its estimate of the transaction price as appropriate.  To date, no amounts have been constrained in the initial or subsequent assessments of the transaction price. The Company did not recognize revenue from other performance obligations included in the Company’s out-licensing agreements during the three and six-month periods ended June 30, 2021 and 2020.

Certain out-license agreements include performance obligations to manufacture and provide drug product in the future for commercial sale when the licensed product is approved. For the commercial, sales-based royalties, the consideration is predominantly related to the licensed IP and is contingent on the customer’s subsequent sales to another commercial customer. Consequently, the sales- or usage-based royalty exception would apply. Revenue will be recognized for the commercial, sales-based milestones as the underlying sales occur. The Company recorded $0.2 million of royalty revenue related to sales of Tirbanibulin during the three and six months ended June 30, 2021. No royalty revenue was recorded during the six months ended June 30, 2020.

The Company exercises significant judgment when identifying distinct performance obligations within its out-license arrangements, determining the transaction price, which often includes both fixed and variable considerations, and allocating the transaction price to the proper performance obligation.  The Company did not use any other significant judgments related to out-licensing revenue during the three and six-month periods ended June 30, 2021 and 2020.

 

2.

Global Supply Chain Platform

The Company’s Global Supply Chain Platform manufactures API for use internally in its research and development activities as well as its clinical studies, and for sale to pharmaceutical customers globally. The Company generates additional revenue on this platform, by providing small to mid-scale cGMP manufacturing of clinical and commercial products for pharmaceutical and biotech companies and selling pharmaceutical products under 503B regulations set forth by the U.S. FDA.

Revenue earned by the Global Supply Platform is recognized when the Company has satisfied its performance obligation, which is the shipment or the delivery of drug products. The underlying contracts for these sales are generally purchase orders and the Company recognizes revenue at a point-in-time. Any remaining performance obligations related to product sales are the result of customer deposits and are reflected in the deferred revenue contract liability balance.

 

3.

Commercial Platform

The Company’s Commercial Platform generates revenue by distributing specialty products through independent pharmaceutical wholesalers. The wholesalers then sell to an end-user, normally a hospital, alternative healthcare facility, or an independent pharmacy, at a lower price previously established by the end-user and the Company. Upon the sale by the wholesaler to the end-user, the wholesaler will chargeback the difference, if any, between the original list price and price at which the product was sold to the end-user. The Company also offers cash discounts, which approximate 2.3% of the gross sales price, as an incentive for prompt customer payment, and, consistent with industry practice, the Company’s return policy permits customers to return products within a window of time before and after the expiration of product dating. Further, the Company offers contractual allowances, generally in the form of rebates or administrative fees, to certain wholesale customers, group purchasing organizations (“GPOs”), and end-user customers, consistent with pharmaceutical industry practices. Revenues are recorded net of provisions for variable consideration, including discounts, rebates, GPO allowances, price adjustments, returns, chargebacks, promotional programs and other sales allowances. Accruals for these provisions are presented in the consolidated financial statements as reductions in determining net sales and as a contra asset in accounts receivable, net (if settled via credit) and other current liabilities (if paid in cash). As of June 30, 2021, and December 31, 2020, the Company’s total provision for chargebacks and other deductions included as a reduction of accounts

23


 

receivable totaled $14.5 million and $12.6  million, respectively. The Company’s total provision for chargebacks and other revenue deductions was $26.9 million, and $20.2 million for the three months ended June 30, 2021, and 2020, respectively, and $52.5 million and $45.1 million for the six months ended June 30, 2021 and 2020, respectively.  

The Company exercises significant judgment in its estimates of the variable transaction price at the time of the sale and recognizes revenue when the performance obligation is satisfied. Factors that determine the final net transaction price include chargebacks, fees for service, cash discounts, rebates, returns, warranties, and other factors. The Company estimates all of these variables based on historical data obtained from previous sales finalized with the end-user customer on a product-by-product basis. At the time of sale, revenue is recorded net of each of these deductions. Through the normal course of business, the wholesaler will sell the product to the end-user, determining the actual chargeback, return products, and take advantage of cash discounts, charge fees for services, and claim warranties on products. The final transaction price per product is compared to the initial estimated net sale price and reviewed for accuracy. The final prices and other factors are immediately included in the Company’s historical data from which it will estimate the transaction price for future sales. The underlying contracts for these sales are generally purchase orders including a single performance obligation, generally the shipment or delivery of products and the Company recognizes this revenue at a point-in-time.

Disaggregation of revenue

The following represents the Company’s revenue for its reportable segment by country, based on the locations of the customer.

 

 

 

For the Three Months Ended June 30, 2021

 

 

 

(In Thousands)

 

 

 

Oncology

Innovation

Platform

 

 

Global Supply

Chain Platform

 

 

Commercial

Platform

 

 

Consolidated

Total

 

United States

 

$

288

 

 

$

4,600

 

 

$

15,791

 

 

$

20,679

 

China

 

 

9

 

 

 

643

 

 

 

 

 

 

652

 

South Korea

 

 

 

 

 

445

 

 

 

 

 

$

445

 

Other foreign countries

 

 

9

 

 

 

138

 

 

 

 

 

 

147

 

Total revenue

 

$

306

 

 

$

5,826

 

 

$

15,791

 

 

$

21,923

 

 

 

 

For the Three Months Ended June 30, 2020

 

 

 

(In Thousands)

 

 

 

Oncology

Innovation

Platform

 

 

Global Supply

Chain Platform

 

 

Commercial

Platform

 

 

Consolidated

Total

 

United States

 

$

 

 

$

2,720

 

 

$

23,281

 

 

$

26,001

 

United Kingdom

 

 

 

 

 

 

 

 

12,933

 

 

 

12,933

 

South Korea

 

 

 

 

 

1,060

 

 

 

 

 

 

1,060

 

China

 

 

5

 

 

 

120

 

 

 

 

 

 

125

 

Other foreign countries

 

 

 

 

 

53

 

 

 

 

 

 

53

 

Total revenue

 

$

5

 

 

$

3,953

 

 

$

36,214

 

 

$

40,172

 

 

 

 

For the Six Months Ended June 30, 2021

 

 

 

(In Thousands)

 

 

 

Oncology

Innovation

Platform

 

 

Global Supply

Chain Platform

 

 

Commercial

Platform

 

 

Consolidated

Total

 

United States

 

$

20,444

 

 

$

9,829

 

 

$

29,050

 

 

$

59,323

 

South Korea

 

 

 

 

 

1,112

 

 

 

 

 

 

1,112

 

India

 

 

 

 

 

906

 

 

 

 

 

 

906

 

China

 

 

17

 

 

 

841

 

 

 

 

 

 

858

 

Other foreign countries

 

 

510

 

 

 

239

 

 

 

 

 

 

749

 

Total revenue

 

$

20,971

 

 

$

12,927

 

 

$

29,050

 

 

$

62,948

 

24


 

 

 

 

 

For the Six Months Ended June 30, 2020

 

 

 

(In Thousands)

 

 

 

Oncology

Innovation

Platform

 

 

Global Supply

Chain Platform

 

 

Commercial

Platform

 

 

Consolidated

Total

 

United States

 

$

 

 

$

4,700

 

 

$

38,822

 

 

$

43,522

 

China

 

 

28,314

 

 

 

324

 

 

 

 

 

 

28,638

 

United Kingdom

 

 

 

 

 

 

 

 

12,933

 

 

 

12,933

 

South Korea

 

 

 

 

 

1,693

 

 

 

 

 

 

1,693

 

Other foreign countries

 

 

79

 

 

 

242

 

 

 

 

 

 

321

 

Total revenue

 

$

28,393

 

 

$

6,959

 

 

$

51,755

 

 

$

87,107

 

 

The Company also disaggregates its revenue by product group which can be found in Note 15 – Business Segment, Geographic, and Concentration Risk Information.

Contract balances

The following table provides information about receivables and contract liabilities from contracts with customers. The Company has not recorded any contract assets from contracts with customers.

 

 

 

June 30,

2021

 

 

December 31,

2020

 

 

 

(In Thousands)

 

Accounts receivable, gross

 

$

46,162

 

 

$

45,792

 

Chargebacks and other deductions

 

 

(14,523

)

 

 

(12,552

)

Provision for credit losses

 

 

(9,421

)

 

 

(9,637

)

Accounts receivable, net

 

$

22,218

 

 

$

23,603

 

Deferred revenue

 

 

1,082

 

 

 

1,147

 

Total contract liabilities

 

$

1,082

 

 

$

1,147

 

 

The following tables illustrate accounts receivable and contract asset balances by reportable segments.

 

 

 

June 30, 2021

 

 

 

(In Thousands)

 

 

 

Oncology

Innovation

Platform

 

 

Global Supply

Chain Platform

 

 

Commercial

Platform

 

 

Consolidated

Total

 

Accounts receivable, gross

 

$

9,170

 

 

$

2,771

 

 

$

34,221

 

 

$

46,162

 

Chargebacks and other deductions

 

 

 

 

 

 

 

 

(14,523

)

 

 

(14,523

)

Provision for credit losses

 

 

(8,919

)

 

 

(178

)

 

 

(324

)

 

 

(9,421

)

Accounts receivable, net

 

 

251

 

 

 

2,593

 

 

 

19,374

 

 

 

22,218

 

 

 

 

December 31, 2020

 

 

 

(In Thousands)

 

 

 

Oncology

Innovation

Platform

 

 

Global Supply

Chain Platform

 

 

Commercial

Platform

 

 

Consolidated

Total

 

Accounts receivable, gross

 

$

10,783

 

 

$

4,074

 

 

$

30,935

 

 

$

45,792

 

Chargebacks and other deductions

 

 

 

 

 

(1

)

 

 

(12,551

)

 

 

(12,552

)

Provision for credit losses

 

 

(8,919

)

 

 

(164

)

 

 

(554

)

 

 

(9,637

)

Accounts receivable, net

 

$

1,864

 

 

$

3,909

 

 

$

17,830

 

 

$

23,603

 

 

As of June 30, 2021 and December 31, 2020, the deferred revenue balances relate to customer deposits made by customers of the Oncology Innovation Platform and Global Supply Chain Platform and are included within accrued expenses on the condensed consolidated balance sheets.    

There were no other material changes to contract balances during the three and six months ended June 30, 2021.

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17. Commitments and Contingencies

Future minimum payments under the non-cancelable operating leases consists of the following as of June 30, 2021 (in thousands):

 

Year ending December 31:

 

Minimum

payments

 

2021 (remaining six months)

 

$

1,716

 

2022

 

 

2,929

 

2023

 

 

2,096

 

2024

 

 

2,002

 

2025

 

 

1,472

 

Thereafter

 

 

478

 

 

 

$

10,693

 

 

Legal Proceedings

Following our receipt of the CRL in February 2021 and the subsequent decline of the market price of the Company’s common stock, two purported securities class action lawsuits were filed in the U.S. District Court for the Western District of New York on March 3, 2021 and March 22, 2021, respectively, against the Company and certain members of its management team seeking to recover damages for alleged violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.

The complaints generally allege that between August 7, 2019 and February 26, 2021 (the purported class period), the Company and the individual defendants made materially false and misleading statements regarding the Company's business in connection with the Company’s development of Oral Paclitaxel for the treatment of metastatic breast cancer and the likelihood of FDA approval, and that the plaintiffs suffered losses when the Company’s stock price dropped after its announcement on February 26, 2021 regarding receipt of the CRL. The complaints seek class certification, damages, fees, costs, and expenses. Motions to appoint a lead plaintiff and consolidate the two cases were fully briefed as of May 17, 2021, and are now pending before the court. The defendants expect that the court will issue an order consolidating these two lawsuits and appointing a lead plaintiff in the coming months. Additional similar lawsuits might be filed. The Company and the individual defendants believe that the claims in these lawsuits are without merit, and the Company has not recorded a liability related to this shareholder class action lawsuit as the risk of loss is remote. The Company and the individual defendants intend to vigorously defend against these claims but there can be no assurances as to the outcome.

Shareholder Derivative Lawsuit

On June 3, 2021, a shareholder derivative lawsuit was filed in the United States District Court for the District of Delaware by Timothy J. Wonnell, allegedly on behalf of the Company, that piggy-backs on the securities class actions referenced above.  The complaint names Johnson Lau, Rudolf Kwan, Timothy Cook, and members of the Board as defendants, and generally alleges that they caused or failed to prevent the securities law violations asserted in the securities class actions. The Company and the individual defendants believe the claims are without merit, and the Company has not recorded a liability related to this lawsuit as the risk of loss is remote. The Company and the individual defendants intend to vigorously defend against these claims but there can be no assurances as to the outcome. 

 

18. Subsequent Event

The Company suspended production activities at its Taihao active pharmaceutical ingredient (API) facility in Chongqing, China, in May 2019, based on concerns raised by the Department of Emergency Management of Chongqing (DEMC) related to the location of our plant. The Company subsequently resumed producing API at the Taihao facility primarily for its ongoing clinical studies and commercial launches of its proprietary drugs in accordance with local regulatory guidance, while the Company started building out Sintaho, a new API facility in Chongqing. In July 2021, the Company received verbal notice from the DEMC that it will be required to terminate the production activities at its Taihao API facility at the end of 2021. The Company is seeking further dialogue with the DEMC. While a certain extent of its operations is now being conducted at Sintaho, its new API facility in Chongqing, the Company is beginning to explore plans to move remainder of the operations and production activities to Sintaho, in the event it is unable to reach an agreement with the DEMC for the continued production activities of the Taihao API facility.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion contains management’s discussion and analysis of our financial condition and results of operations and should be read together with the unaudited condensed consolidated financial statements and the notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q and with our audited consolidated financial statements and related notes thereto for the year ended December 31, 2020 included in our Annual Report on Form 10-K for the year ended December 31, 2020. Unless the context indicates otherwise, as used in this Quarterly Report, the terms “Athenex,” the “Company,” “we,” “us,” and “our” refer to Athenex, Inc., a Delaware corporation, and its subsidiaries taken as a whole, unless otherwise noted. This discussion and other parts of this Quarterly Report contain forward-looking statements that involve risks and uncertainties, such as our plans, objectives, expectations, intentions and beliefs. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section entitled “Risk Factors” included in our Annual Report on Form 10-K for the year ended December 31, 2020.

NOTE ABOUT FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and section 27A of the Securities Act of 1933, as amended (the “Securities Act”). All statements other than statements of historical fact are “forward-looking statements” for purposes of this Quarterly Report. These forward-looking statements may include, but are not limited to, statements regarding our future results of operations and financial position, business strategy, potential market size, potential growth opportunities, the timing and results of clinical trials, the impact of COVID-19 on our business, and potential regulatory approval and commercialization of product candidates. In some cases, forward-looking statements may be identified by terminology such as “believe,” “may,” “will,” “should,” “predict,” “goal,” “strategy,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect,” “seek” and similar expressions and variations thereof. These words are intended to identify forward-looking statements.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in the “Risk Factors” section included in our Annual Report on Form 10-K for the year ended December 31, 2020 and the additional risk factors described herein. Moreover, we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business. In light of these risks, uncertainties and assumptions, actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. We undertake no obligation to update publicly any forward-looking statements for any reason after the date hereof to conform these statements to actual results or to changes in our expectations, except as required by law.

Overview and Recent Developments

We are a biopharmaceutical company dedicated to becoming a leader in the discovery, development and commercialization of next generation drugs for the treatment of cancer. Our mission is to improve the lives of cancer patients by creating more effective, safer and tolerable treatments. We have assembled a strong and experienced leadership team and have established operations across the pharmaceutical value chain to execute our goal of becoming a global leader in bringing innovative cancer treatments to the market and improving health outcomes.

We are organized around three operating segments: (1) our Oncology Innovation Platform, dedicated to the research and development of our proprietary drugs; (2) our Commercial Platform, focused on the sales and marketing of our specialty drugs and the market development of our proprietary drugs; and (3) our Global Supply Chain Platform, dedicated to providing a stable and efficient supply of APIs for our clinical and commercial efforts. Our current clinical pipeline in the Oncology Innovation Platform is derived from four different technologies: (1) Orascovery, based on a P-glycoprotein (“P-gp”) pump inhibitor, (2) Src Kinase Inhibition, (3) Cell Therapy, and (4) Arginine Deprivation Therapy.

The following table summarizes the development status of our current pipeline of product candidates as of June 30, 2021:

 

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On July 19, 2021, we announced that our partner, Almirall (Almirall, S.A., BME: ALM), had received approval from the European Commission to market Klisyri® (tirbanibulin) for the topical treatment of actinic keratosis (AK) of the face or scalp in adults. Almirall launched Klisyri in the U.S. in February 2021 after Athenex received approval from the FDA for the commercialization of Klisyri in the United States for the same drug indication usage in December 2020. Almirall will be launching the product in Europe. The launch in the U.S. resulted in a milestone payment of $20.0 million pursuant to the license agreement.

In June 2021, we held a Type A meeting with the FDA after receiving in February 2021 a Complete Response Letter (“CRL”), in which the agency indicated its concern of safety risk to patients in terms of an increase in neutropenia-related sequelae on the Oral Paclitaxel arm compared with the IV paclitaxel arm in the Phase III study, and also its concern of the uncertainty over the results of the primary endpoint of objective response rate (ORR) at week 19 conducted by blinded independent central review (BICR), and recommended that we conduct a new adequate and well-conducted clinical trial in a patient population with metastatic breast cancer representative of the population in the U.S. The agency determined that adequate risk mitigation strategies to improve toxicity, which may involve dose optimization and / or exclusion of patients deemed to be at higher risk of toxicity, would be required in any new clinical trial of Oral Paclitaxel. At the Type A meeting, we provided additional analyses, including overall survival (OS) data on patient subgroups, to provide a more comprehensive summary of the risk/benefit assessment. We also proposed to collect additional OS data that could inform the design of a new clinical study. The FDA was supportive and encouraged the Company to continue development of oral paclitaxel and encequidar for the treatment of metastatic breast cancer. The FDA also agreed that a well-designed and well-conducted trial may adequately address the deficiencies raised in the CRL. We are evaluating the optimal design for a new clinical study which we intend to present to the FDA in the fourth quarter of 2021.

We are also evaluating Oral Paclitaxel in other indications and in combination with other therapies. We completed enrollment in our Phase 2 study of Oral Paclitaxel in the treatment of cutaneous angiosarcoma and intend to discuss a registration pathway with the FDA. Our Phase 1 study of Oral Paclitaxel in combination with pembrolizumab, or Keytruda, in patients with advanced solid malignancies is ongoing. Athenex has an abstract accepted for poster presentation at the European Society of Medical Oncology

28


 

(ESMO) Congress 2021, taking place in September 2021, to present dose finding results from this study. We are proceeding into the expansion phase of the Oral Paclitaxel in combination with pembrolizumab study. The I-SPY 2 trial evaluating Oral Paclitaxel in combination with dostarlimab in neoadjuvant breast cancer patients is also ongoing.

In addition to our lead Orascovery product candidate, development of our other Orascovery product candidates is ongoing. We are planning Phase 2 studies for both oral irinotecan and encequidar (“Oral Irinotecan”) and oral docetaxel and encequidar (“Oral Docetaxel”). A Phase 1 study of oral eribulin and encequidar (“Oral Eribulin”) in patients with solid tumors is ongoing.

On May 4, 2021, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Kuur Therapeutics, Inc., a Delaware corporation (formerly known as Cell Medica, “Kuur”). Kuur is a clinical-stage biopharmaceutical company focused on the development of allogeneic, or “off-the-shelf”, NKT (natural killer T) cell immunotherapies for the treatment of solid and hematological malignancies. Kuur’s immunotherapy platform engineers chimeric antigen receptors (“CARs”) expressed by invariant NKT cells, which combine features of T and NK cells, and is being developed in partnership with Baylor College of Medicine and Texas Children’s Hospital. Allogeneic cell therapy has the potential to be faster and less expensive than patient-specific autologous products, and NKT cells offer several advantages over other cell types for allogeneic immunotherapy applications. NKT cells have the cytotoxic and anti-tumor properties of conventional T cells, but with other biological attributes that are expected to improve their ability to attack hematological and solid tumors. These include amplification of the immune response, innate tissue and solid tumor homing properties, as well as endogenous anti-tumor activity based on the ability to eliminate immune suppressive cells and activate host immune cells within the tumor microenvironment.

Kuur has two principal agreements with Baylor College of Medicine (“Baylor”), an Amended and Restated Exclusive License and Option Agreement dated February 28, 2020 (the “Baylor License Agreement”) and an Amended and Restated Co-Development Agreement dated February 28, 2020 (the “Baylor Co-Development Agreement”), each entered into by Kuur Therapeutics Limited (f/k/a Cell Medica, Ltd.) (“Kuur Ltd”) to amend and restate agreements that have been in place since 2016. In August 2020, Kuur Ltd assigned its obligations under the Baylor License Agreement and the Baylor Co-Development Agreement to Cell Medica, Inc. (“Cell Medica”), a sister company to Kuur Ltd. and direct subsidiary of Kuur. Under the Baylor License Agreement and Baylor Co-Development Agreement, Kuur has an exclusive licensing and co-development agreement around cellular immunotherapy products for the treatment of cancer and pursuant to which the parties to the agreement have been advancing Kuur’s pipeline of three product candidates, KUR-501 and KUR-502 into the clinic, and in advancing KUR-503 into IND-enabling preclinical studies. Per the terms of the Baylor Co-Development Agreement, Baylor is responsible for the development activities, at Kuur’s cost pursuant to an annual budget, determined by and under the supervision of a joint steering committee that is composed of four Baylor appointees and four Kuur appointees. The Baylor Co-Development Agreement is coterminous with the Baylor License Agreement or on breach or at Kuur’s option upon twelve months’ notice with such termination effective no earlier than three years from the date of the agreement.

Under the terms and conditions of the Baylor License Agreement, Baylor has granted Kuur a royalty bearing, worldwide, exclusive license under its technology in the permitted fields of use to research, develop, commercialize, and manufacture the licensed products with options to extend the scope and Kuur will be responsible for the commercialization of the licensed product in their permitted fields of use. Kuur has agreed to pay Baylor payments up to $128.5 million in the event defined development and sales are achieved, as well as tiered royalties at single digit rates based on annual net sales of licensed products and tiered percentages of sublicensing revenue ranging from mid-single digits to royalty rates in the mid-teens.    

The Baylor License Agreement will continue until the patent rights under the agreement expire on a country-by-country basis, unless terminated earlier in accordance with the terms of the Baylor License Agreement. The agreement may be terminated on a product-by-product basis or in its entirety upon the mutual agreement of the parties, by Kuur upon requisite notice, on insolvency of a party or by either party for material breach as set forth in the Baylor License Agreement.

KUR-501 is an autologous product in which NKT cells are engineered with a CAR targeting GD2, which is expressed on almost all neuroblastoma tumors, as well as other malignancies. KUR-501 is being tested in the phase 1 GINAKIT2 clinical study in patients with relapsed-refractory (R/R) high risk neuroblastoma. The single-arm study will evaluate six dose levels of KUR-501 with patients receiving pre-dose lymphodepletion chemotherapy consisting of cyclophosphamide and fludarabine. Neuroblastoma is a pediatric cancer and patients with R/R high risk neuroblastoma have a poor prognosis and a significant unmet medical need. The KUR-501 development program is also designed to provide autologous proof-of-concept for CAR-NKT cells in solid tumors using a validated target. The GINAKIT2 study is supported by Kuur Therapeutics and conducted by Kuur’s collaborator, Baylor College of Medicine (“BCM”), and is currently recruiting patients.

KUR-502 is an allogeneic product in which NKT cells are engineered with a CAR targeting CD19. KUR-502 is built on Kuur’s next-generation CAR-NKT platform with novel engineering capabilities that harness and enhance the unique properties of NKT cells. The NKT cells used in Kuur’s CAR-NKT platform have a semi-invariant TCR that does not distinguish between self- and non-self-tissues, making the cells unlikely to induce graft versus host disease (GvHD).  As a result, KUR-502 cells are harvested and manufactured from healthy donors. The ANCHOR clinical study is a phase 1, first-in-human, dose escalation evaluation of KUR-502 in adults with R/R CD19 positive malignancies including B cell lymphomas, acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL). The single-arm study will evaluate three dose levels with patients receiving lymphodepletion

29


 

chemotherapy consisting of cyclophosphamide and fludarabine followed by infusion with KUR-502. Patients with R/R CD19-positive malignancies have limited effective treatment options. While CD19-directed autologous CAR-T cells are now available for these patients, they are limited by a requirement for patient leukapheresis, delays to receive treatment due to the requirement for autologous manufacturing, limited access, and variable final product quality. Off-the-shelf KUR-502 is designed to overcome these limitations. The ANCHOR study is being sponsored and conducted by Kuur’s collaborator, BCM and is currently recruiting patients.

KUR-503 is a product, in which NKT cells are engineered with a CAR targeting GPC3 (glypican-3).  GPC3 is a molecule that is highly expressed on most hepatocellular carcinomas (HCC), but not normal liver or other non-neoplastic tissue, making it an ideal target. Because NKT cells home to the liver, they are excellent candidates to deliver immune effector therapy for patients with HCC. HCC is now the fourth most common cause of cancer related death worldwide, with an estimated 750,000 new cases each year. Although there have been some recent approvals of new agents to treat advanced HCC, these patients still have poor outcomes and there is a significant unmet need. KUR-503 is currently in preclinical development and the company is planning to submit an IND in 2022.

We believe that the acquisition of Kuur can potentially launch its cell therapy product portfolio to be one of the leaders in cell therapy. Kuur’s pipeline enables us to expand the cell therapy R&D pipeline by adding to Athenex’s current T cell receptor (TCR)-T immunotherapy program. The first cell therapy product in the TCR-T immunotherapy program, TCRT-ESO-A2, is based on an autologous approach of transducing a patient’s T cells with a T cell receptor (TCR) that recognizes a cancer antigen derived from the protein NYESO-1. The broad applicability of NKT cells allow for insertion of a CAR to target hematological malignancies and a TCR to target solid tumors

Pursuant to the terms of the Merger Agreement, we paid $70.0 million upfront to Kuur shareholders and its former employees and directors, comprised primarily of equity in the Company’s common stock. Additionally, Kuur shareholders and its former employees and directors are eligible to receive up to $115.0 million of milestone payments, which may be paid, at the Company’s sole discretion, in either cash or additional common stock of the Company, or a combination of both (see Footnote 5 Business Combination).

The other technology in our Cell Therapy platform is our TCR-T immunotherapy technology under which we are advancing TCR affinity-enhancing specific T-cell (TAEST) therapy with our first T cell therapy product, TCRT-ESO-A2. We are planning to begin enrollment for the Phase 1 trial of TCRT-ESO-A2 in the third quarter of 2021. TCRT-ESO-A2, an autologous T cell receptor (TCR)-T cell therapy targeting solid tumors that are NY-ESO-1 positive in HLA-A*02:01 positive patients.

We are still in the process of evaluating the impact of the acquisition of Kuur on our business. Kuur is still in early stage development of its product candidates and we expect to incur significant research and development expenses as we advance the cell therapy business, including the payment of milestone payments and royalties under Kuur’s in-licensing arrangements. We are also in the early stages of integrating Kuur’s business and we may not recognize any synergies and other benefits of the acquisition in the near term as we work to integrate Kuur’s business.

With respect to Arginine deprivation therapy, the Phase 1 trial of PT01 for the treatment of patients with advanced malignancies is currently enrolling patients.

COVID-19 related measures and recent business updates

Since early 2020, after monitoring developments related to the spread of COVID-19, we have undertaken a number of measures in response to the COVID-19 pandemic, with a goal to prioritize the health and safety of our employees and ensure continuity in our business. These measures included implementing a work-from-home policy at various times and other efforts in accordance with recommendations by local authorities for certain of our personnel across the globe as well as imposing restrictions on travel and in-person meetings to protect the health and safety of our workforce while we continue to advance our clinical programs and operations. We have continued to add additional safety procedures and tools in all our locations. We adhere to all state and federal requirements as the same may be in force from time to time.

We have been deemed an “essential business” by New York State and, as a result, we have experienced minimal disruptions at our New York-based operations in Clarence and Buffalo. Despite these efforts, we may from time to time experience additional disruptions related to the COVID-19 pandemic resulting from employees falling ill with COVID-19. We have supplied our employees with face coverings and other necessary personal protective equipment and have taken other measures to reduce the risk of the spread of COVID-19 at our work sites. We are actively monitoring our operations and supply chain across the globe and are making adjustments to respond to logistical challenges that arise due to the COVID-19 pandemic where appropriate, particularly due to the emergence and spread of the COVID-19 Delta variant, which has already impacted our operations and supply chain in the first half of 2021 as discussed further below. We have continued to produce medicines that are used to treat COVID-19 as part of our commitment to contribute to the COVID-19 relief effort.

With respect to our clinical development program, for our earlier stage product candidates, we have experienced and expect to continue to experience slowed enrollment for our clinical trials as well as suspensions in our clinical trials as healthcare resources are

30


 

diverted to address the COVID-19 pandemic. We remain committed to advancing our pipeline while ensuring the safety of all participants as well as the integrity of the data. We will continue to monitor developments with respect to the COVID-19 pandemic as well as industry and regulatory best practices for continuing clinical development programs during the pandemic, including, if and where appropriate, the use of virtual communications, interviews and visits as well as self-administration and remote monitoring techniques to address health and safety concerns while minimizing disruptions and delays to our clinical development timelines.

We also put in place a number of measures intended to adjust or allocate resources towards prioritizing key business operations such as clinical and regulatory activities for later-stage product candidates and pre-launch commercial activities, and to delay or defray compensation costs in order to preserve our cash on hand and liquidity during a volatile period in the U.S. and global capital markets.

However, a lack of sustained recovery or further deterioration in market conditions related to the general economy and the industries in which we operate, a sustained trend of weaker than anticipated financial performance, further decline in our share price for a sustained period of time, or an increase in the market-based weighted average cost of capital, among other factors, could significantly impact the impairment analysis and may result in future impairment charges that, if incurred, could have a material adverse effect on our financial condition and results of operations.

While the disruptions to our business caused by the pandemic are currently expected to be temporary, there is still uncertainty regarding the pandemic's overall duration and the severity of any future outbreaks. The surge of COVID-19 cases in the last couple of months in India, a country where we source supplies and maintain partnerships that are key to our specialty drug business, including API, presents business and supply chain disruption risks for us to the extent the virus is not able to be contained, there is widespread sickness and disruptions on operations and also in the event state governments in India impose additional lockdowns, restrictions on the operations of businesses and other containment measures to combat the spread of the virus. The scope and impact of any such measures is not yet known and will depend on a number of factors, including the ultimate spread and severity of the outbreaks in India and the scope, duration and impact of containment measures on individuals and businesses. If our partners in India experience significant or extended disruptions to their business due to COVID-19, it could result in substantial supply shortages and harm our special drug business, as well as our overall financial condition and results of operations.

As a result of the significant decrease in our market capitalization since we last performed a goodwill impairment test in the fourth quarter of 2020, we evaluated the impact on each of its reporting units to assess whether there was a triggering event during the first quarter of 2021, requiring it to perform a goodwill impairment test (ASC350-20-35). We determined a triggering event occurred and, as such, performed an interim goodwill quantitative impairment test for our reporting units. We compared the fair value of our Global Supply Chain Platform and Oncology Innovation Platform reporting units to carrying value. Based on the results, the fair value of each of our reporting units exceeded their carrying value, and the goodwill was not impaired (see Note 6 Intangible Assets, Net). However, there can be no assurances that goodwill will not be impaired in future periods. Estimating the fair value of goodwill requires the use of estimates and significant judgments that are based on a number of factors. These estimates and judgments may not be within our control and accordingly it is reasonably possible that the judgments and estimates could change in future periods.

We have three operating segments: our Oncology Innovation Platform, Global Supply Chain Platform and Commercial Platform. Since inception, we have devoted a substantial amount of our resources to research and development of our lead product candidates under our Orascovery and Src Kinase Inhibition technology platforms, as well as under the Cell Therapy platform and Arginine Deprivation Therapy technology, and to buildup of our commercial infrastructure. We have incurred significant net losses since inception.

For the six months ended June 30, 2021, our net loss was $59.3 million, compared to $60.8 million for the same period in 2020. As of June 30, 2021 and December 31, 2020, we had an accumulated deficit of $773.0 million and $713.6 million, respectively. We expect to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses will cover the following activities as we:

 

Continue to advance our lead programs, Orascovery and Src Kinase Inhibition technology platforms, through clinical and regulatory development;

 

Advance the research and clinical development activities of our cell therapy programs, including the development of Kuur’s pipeline and our TCR-T immunotherapy product;

 

Continue certain of our current preclinical and clinical research program and development activities;

 

Continue to invest in our manufacturing facilities in Dunkirk and Chongqing;  

 

Continue to advance the preclinical and clinical research program and development activities of our in-licensed technology platforms;

 

Seek to identify additional research programs and product candidates within existing platform technologies;

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Attain new drugs and technologies through acquisitions or in-licensing opportunities if complementary to our core business;

 

Hire additional research, development and business personnel;

 

Maintain, expand and protect our intellectual property (“IP”) portfolio; and

 

Incur additional costs associated with operating as a public company.

We have borrowed and, in the future, may borrow additional capital from institutional and commercial banking sources to fund future growth, including pursuant to our Senior Credit Agreement and Revenue Interest Financing Agreement, or potentially pursuant to new arrangements with different lenders. We may borrow funds on terms that may include restrictive covenants, including covenants that restrict the operation of our business, liens on assets, high effective interest rates, financial performance covenants and repayment provisions that reduce cash resources and limit future access to capital markets. In addition, we expect to continue to opportunistically seek access to the equity capital markets to support our development efforts and operations. To the extent that we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution. To the extent that we raise additional funds through collaboration or partnering arrangements, we may be required to relinquish some of our rights to our technologies or rights to market and sell our products in certain geographies, grant licenses on terms that are not favorable to us, or issue equity that may be substantially dilutive to our stockholders.

We have funded our operations to date primarily from the issuance and sale of our common stock through public offerings, senior secured loans, private placements, and to a lesser extent, from convertible bond financing, revenue, and grant funding. As of June 30, 2021, we had cash and cash equivalents of $76.9 million, restricted cash of $16.5 million, and short-term investments of $53.3 million.

Key Components of Results of Operations

Revenue

We derive our consolidated revenue primarily from (i) the sales of generic injectable products by our Commercial Platform; (ii) licensing and collaboration projects conducted by our Oncology Innovation Platform, which generates revenue in the form of upfront payments, milestone payments, and payments received for providing research and development services for our collaboration projects and for other third parties; (iii) the sales of 503B and API products by our Global Supply Chain Platform; and (iv) grant awards from government agencies and universities for our continuing research and development efforts.

We do not anticipate revenue being generated from sales of our product candidates under development in our Oncology Innovation Platform until we have obtained regulatory approval. We cannot assure you that we will succeed in achieving regulatory approval for our drug candidates as planned, or at all.

Cost of Sales

Along with sourcing from third-party manufacturers, we manufacture clinical products in our cGMP facility in New York. Cost of sales primarily includes the cost of finished products, raw materials, labor costs, manufacturing overhead expenses and reserves for expected scrap, as well as transportation costs. Cost of sales also includes depreciation expense for production equipment, changes to our excess and obsolete inventory reserves, certain direct costs such as shipping costs, net of costs charged to customers, and royalty costs related to in-license agreements.

Research and Development Expenses

Research and development (“R&D”) expenses consist of the costs associated with in-licensing of product candidates, milestone payments, conducting preclinical studies and clinical trials, activities related to regulatory filings and correspondences, and other R&D activities. Our current R&D activities mainly relate to the clinical development of our Oncology Innovation Platform.

We expense R&D costs as incurred. We record costs for certain development activities, such as clinical trials, based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment or clinical site activations. We do not allocate employee-related costs, depreciation, rental and other indirect costs to specific R&D programs because these costs are deployed across multiple product programs under R&D.

32


 

We cannot determine with certainty the duration, costs and timing of the current or future preclinical or clinical studies of our drug candidates. The duration, costs, and timing of clinical studies and development of our drug candidates will depend on a variety of factors, including:

 

The scope, rate of progress, and costs of our ongoing, as well as any additional, clinical studies, regulatory activities, and other R&D activities;

 

Future clinical study results;

 

Uncertainties in clinical study enrollment rates;

 

Significant and changing government regulation; and

 

The timing and receipt of any regulatory approvals.

A change in the outcome of any of these variables with respect to the development of a drug candidate, including without limitation delays caused by the ongoing COVID-19 pandemic, could mean a significant change in the costs and timing associated with the development of that drug candidate.

R&D activities are central to our business model. We expect our R&D expenses to continue to increase for the foreseeable future as we continue to support the clinical and regulatory development activities of our Orascovery platform product candidates, our Src kinase inhibition platform product candidates, our Cell therapy platform product candidates, as well as initiate and prepare for additional clinical and preclinical studies, including for our arginine biologics products and other small molecule programs. We also expect spending to increase in the R&D for API, 503B and specialty products. There are numerous factors associated with the successful commercialization of any of our drug candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. Additionally, future commercial, regulatory and public health, including the ongoing COVID-19 pandemic, factors beyond our control will likely impact our clinical development programs and plans.

Selling, General and Administrative Expenses

Selling, general and administrative, (“SG&A”), expenses primarily consist of compensation, including salary, employee benefits and stock-based compensation expenses for sales and marketing personnel, and for administrative personnel that support our general operations such as executive management, legal counsel, financial accounting, information technology, and human resources personnel. SG&A expenses also include professional fees for legal, patent, consulting, auditing and tax services, as well as other direct and allocated expenses for rent and maintenance of facilities, development of the facility in Dunkirk, NY, insurance and other supplies used in the selling, marketing, general and administrative activities. SG&A expenses also include costs associated with our commercialization efforts for our proprietary drugs, such as market research, brand strategy and development work on market access, scientific publication, product distribution, and patient support.

We anticipate that our SG&A expenses will increase in future periods to support increases in our research and development. We expect these increases will likely result in increased headcount, increased share compensation charges, expanded infrastructure and increased costs for insurance. We also anticipate increases to legal expenses due to the on-going class action lawsuit (see Note 17 Commitments and Contingencies), insurance premium, compliance, accounting and investor and public relations expenses associated with being a public company.

33


 

Results of Operations

Three Months Ended June 30, 2021 Compared to Three Months Ended June 30, 2020

The following table sets forth a summary of our condensed consolidated results of operations for the three months ended June 30, 2021 and 2020, together with the changes in those items in dollars and as a percentage. This information should be read together with our condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q. Our operating results in any period are not necessarily indicative of the results that may be expected for any future period.

 

 

 

Three Months Ended June 30,

 

 

 

2021

 

 

2020

 

 

Change

 

 

 

(in thousands)

 

 

(in thousands)

 

 

(in thousands)

 

 

%

 

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales, net

 

$

21,385

 

 

$

40,167

 

 

$

(18,782

)

 

 

-47

%

License fees and other revenue

 

 

538

 

 

 

5

 

 

 

533

 

 

NM

 

Total revenue

 

 

21,923

 

 

 

40,172

 

 

 

(18,249

)

 

 

 

 

Cost of sales

 

 

(19,663

)

 

 

(33,006

)

 

 

13,343

 

 

 

-40

%

Gross profit

 

 

2,260

 

 

 

7,166

 

 

 

(4,906

)

 

 

 

 

Research and development expenses

 

 

(21,127

)

 

 

(22,015

)

 

 

888

 

 

 

-4

%

Selling, general, and administrative expenses

 

 

(21,231

)

 

 

(17,486

)

 

 

(3,745

)

 

 

21

%

Interest income

 

 

132

 

 

 

185

 

 

 

(53

)

 

 

-29

%

Interest expense

 

 

(5,684

)

 

 

(1,565

)

 

 

(4,119

)

 

 

263

%

Loss on extinguishment of debt

 

 

 

 

 

(7,230

)

 

 

7,230

 

 

 

-100

%

Income tax benefit (expense)

 

 

11,035

 

 

 

(106

)

 

 

11,141

 

 

NM

 

Net loss

 

 

(34,615

)

 

 

(41,051

)

 

 

6,436

 

 

 

 

 

Less: net loss attributable to non-controlling interests

 

 

(341

)

 

 

(600

)

 

 

259

 

 

 

-43

%

Net loss attributable to Athenex, Inc.

 

$

(34,274

)

 

$

(40,451

)

 

$

6,177

 

 

 

 

 

 

*NM used to indicate a percentage change that is not meaningful

 

Revenue

Revenue from product sales decreased to $21.4 million for the three months ended June 30, 2021, from $40.2 million for the three months ended June 30, 2020, a decrease of $18.8 million or 47%. This decrease was primarily attributable to a decrease in APD product sales of $20.4 million primarily as the result of a decrease in demand for COVID-19 related drugs from the prior year, including some significant non-recurring orders of approximately $14.1 million. In addition, in the first half of 2021, we experienced significant COVID-related challenges in our Indian supply chain and to a lesser extent in China. As a result, we did not receive some inventory from our partners located in these countries for a certain period of time. We also experienced a higher amount of product sales in 2020 because we started fulfilling demand for certain drugs used to treat patients hospitalized with COVID in the U.S. and demand for FDA shortage products. As a result, the product revenues in the second quarter of last year were particularly high, given the COVID pandemic had just started. Fluctuations in the infection rate and the spread of the global health pandemic and market demand may continue to significantly affect our product sales in the future. API product sales decreased by $0.2 million. These were partially offset by an increase in 503B and contract manufacturing revenue of $1.5 million and $0.4 million, respectively.

License fees and other revenue increased by $0.5 million, for the three months ended June 30, 2021. This increase was primarily due to $0.2 million grant revenue and $0.2 million in royalties received from Almirall for the sales of Klisyri after the product launch in the U.S. in February 2021.

Cost of Sales

Cost of sales for the three months ended June 30, 2021 totaled $19.7 million, a decrease of $13.3 million, or 40%, as compared to $33.0 million for the three months ended June 30, 2020. The decrease was primarily due to a decrease of $13.1 million in cost of APD product sales, generally in-line with the decrease in the product sales. Additionally, cost of sales related to royalties for license income decrease by $1.2 million from the royalty payment incurred in 2020 on the license revenue from Xiangxue. Cost of API product sales decreased by $0.3 million. Cost of 503B product sales increased by $1.3 million as production levels increased.

Research and Development Expenses

R&D expenses for the three months ended June 30, 2021 totaled $21.1 million, a decrease of $0.9 million, or 4%, as compared to $22.0 million for the three months ended June 30, 2020. This was primarily due to a decrease in regulatory costs, clinical operations, and preclinical operations and included the following:

34


 

 

$4.0 million decrease in regulatory costs related to the preparation of NDA’s in the prior year;

 

$2.6 million decrease in clinical operations after completion of the Phase 3 studies for tirbanibulin ointment and Oral Paclitaxel; and

 

$1.4 million decrease in preclinical operations, primarily related to docetaxel and paclitaxel.

The decrease in these R&D expenses was partially offset by a $3.3 million increase in oral paclitaxel and encequidar API costs in preparation for product launch, a $2.6 million increase in drug licensing costs, primarily due to a license milestone payment related to Arginine deprivation therapy, a $0.9 million increase in R&D related compensation expenses, and a $0.3 million increase in 503B and cell therapy development costs.

Selling, General, and Administrative Expenses

SG&A expenses for the three months ended June 30, 2021 totaled $21.2 million, an increase of $3.7 million, or 21%, as compared to $17.5 million for the three months ended June 30, 2020. This was primarily due to a $3.5 million increase in professional fees and other expenses related to the acquisition of Kuur, a $1.2 million increase in compensation related costs, a $0.4 million increase from the change in fair value of contingent consideration, and an increase of $0.3 million in operating costs including insurance costs and IT costs. These increases were partially offset by a $1.7 million decrease of costs for preparing to commercialize Oral Paclitaxel as significant pre-launch activities occurred in 2020 and slowed upon receipt of the Complete Response Letter in February 2021.

Interest Income and Interest Expense

Interest income consisted of interest earned on our short-term investments totaled $0.1 million and $0.2 million for the three months ended June 30, 2021 and 2020, respectively. Interest expense totaled $5.7 million and $1.6 million for the three months ended June 30, 2021 and 2020, respectively. Interest expense in the current period was incurred from the Senior Credit Agreement with Oaktree and the write-off of deferred debt issuance costs related to the revenue interest financing, while interest expense in the prior period was primarily incurred from debt under a former credit agreement with Perceptive Advisors LLC and its affiliates.

Income Tax (Benefit) Expense

For the three months ended June 30, 2021, income tax benefit amounted to $11.0 million, compared to income tax expense of $0.1 million for the same period in 2020. The income tax benefit is primarily the result of taxable temporary difference due to the deferred tax liability recognized for the indefinite lived intangible assets acquired in connection with the acquisition of Kuur’s IPR&D. This taxable temporary difference is considered a source of taxable income to support the realization of deferred tax assets from the acquirer which resulted in a reversal of our valuation allowance. The income tax expense in the prior year was primarily attributable to foreign income tax withholdings on our revenue earned under our out-license arrangements.

Six Months Ended June 30, 2021 Compared to Six Months Ended June 30, 2020

The following table sets forth a summary of our condensed consolidated results of operations for the six months ended June 30, 2021 and 2020, together with the changes in those items in dollars and as a percentage. This information should be read together with our condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q. Our operating results in any period are not necessarily indicative of the results that may be expected for any future period.

35


 

 

 

 

Six Months Ended June 30,

 

 

 

2021

 

 

2020

 

 

Change

 

 

 

(in thousands)

 

 

(in thousands)

 

 

(in thousands)

 

 

%

 

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales, net

 

$

41,745

 

 

$

58,714

 

 

$

(16,969

)

 

 

-29

%

License fees and other revenue

 

 

21,203

 

 

 

28,393

 

 

 

(7,190

)

 

 

-25

%

Total revenue

 

 

62,948

 

 

 

87,107

 

 

 

(24,159

)

 

 

 

 

Cost of sales

 

 

(36,068

)

 

 

(52,578

)

 

 

16,510

 

 

 

-31

%

Gross profit

 

 

26,880

 

 

 

34,529

 

 

 

(7,649

)

 

 

 

 

Research and development expenses

 

 

(44,197

)

 

 

(39,207

)

 

 

(4,990

)

 

 

13

%

Selling, general, and administrative expenses

 

 

(43,351

)

 

 

(43,234

)

 

 

(117

)

 

 

0

%

Interest income

 

 

161

 

 

 

598

 

 

 

(437

)

 

 

-73

%

Interest expense

 

 

(10,592

)

 

 

(3,238

)

 

 

(7,354

)

 

 

227

%

Loss on extinguishment of debt

 

 

 

 

 

(7,230

)

 

 

7,230

 

 

NM

 

Income tax benefit (expense)

 

 

10,881

 

 

 

(2,987

)

 

 

13,868

 

 

NM

 

Net loss

 

 

(60,218

)

 

 

(60,769

)

 

 

551

 

 

 

 

 

Less: net loss attributable to non-controlling interests

 

 

(894

)

 

 

(889

)

 

 

(5

)

 

 

1

%

Net loss attributable to Athenex, Inc.

 

$

(59,324

)

 

$

(59,880

)

 

$

556

 

 

 

 

 

 

*NM used to indicate a percentage change that is not meaningful

Revenue

Revenue from product sales decreased to $41.7 million for the six months ended June 30, 2021, from $58.7 million for the six months ended June 30, 2020, a decrease of $17.0 million or 29%. This decrease was primarily attributable to a significant prior year increase in APD product sales of $22.7 million as the result of increased demand for COVID-19 related drugs and for FDA shortage products during 2020, including some significant non-recurring orders. In addition, in the first half of 2021, we experienced significant COVID-related challenges in our Indian supply chain and to a lesser extent in China. As a result, we were not able to receive some inventory from our partners located in these regions for a certain period of time. Fluctuations in the infection rate and the spread of the global health pandemic and market demand may continue to significantly affect our product sales in the future. This decrease was partially offset by an increase in 503B product sales, contract manufacturing revenue, and API product sales of $4.4 million, $0.8 million, and $0.6 million, respectively.

License fees and other revenue decreased to $21.2 for the six months ended June 30, 2021, from $28.4 million for the six months ended June 30, 2020, a decrease of $7.2 million, or 25%. For the six months ended June 30, 2021, we recorded $20.0 million of license revenue pursuant to the 2017 Almirall License Agreement upon the launch of Klisyri in the U.S. in February 2021, and $0.5 million related to the upfront fee pursuant to the Second Amendment to the 2011 PharmaEssentia License Agreement. For the six months ended June 30, 2020 we recognized $28.3 million in license revenue, net of $1.7 million value added tax (“VAT”), pursuant to the 2019 Xiangxue License Agreement.

Cost of Sales

Cost of sales for the six months ended June 30, 2021 totaled $36.1 million, a decrease of $16.5 million, or 31%, as compared to $52.6 million for the six months ended June 30, 2020. The decrease was primarily due to a decrease of $14.4 million in cost of APD product sales, generally in-line with the decrease in the product sales. Cost of sales related to royalties for license income also decreased by $3.2 million from the royalty payment incurred in 2020 on the license revenue from Xiangxue. Cost of 503B product sales increased by $1.3 million as production levels increased.

Research and Development Expenses

R&D expenses for the six months ended June 30, 2021 totaled $44.2 million, an increase of $5.0 million, or 13%, as compared to $39.2 million for the six months ended June 30, 2020. This was primarily due to an increase in costs related to Oral Paclitaxel, drug licensing costs, compensation, and preclinical operations, and included the following:

 

$9.6 million increase in Oral Paclitaxel product development, API, and medical affairs costs associated with the potential product launch in 2021;

 

$2.8 million increase in drug licensing costs, primarily due to a license milestone payment related to Arginine deprivation therapy;

36


 

 

$1.3 million increase in R&D related compensation expenses; and

 

$0.9 million increase in preclinical operations costs related to our cell therapy platform.

 

 

The increase in these R&D expenses was partially offset by a decrease of $5.4 million in clinical operations after completion of the Phase 3 studies for tirbanibulin ointment and Oral Paclitaxel, a decrease of $4.1 million in regulatory costs in connection with our NDA preparations, and decrease of $0.1 million in 503B product development.

Selling, General, and Administrative Expenses

SG&A expenses for the six months ended June 30, 2021 totaled $43.4 million, an increase of $0.1 million, or 0%, as compared to $43.2 million for the six months ended June 30, 2020. This was primarily due to a $3.5 million increase in professional fees and other expenses related to the acquisition of Kuur, a $1.9 million increase in compensation related costs, an increase of $1.2 million in operating costs including insurance costs and IT costs, and a $0.4 million increase from the change in fair value of contingent consideration. These increases were partially offset by a $6.1 million decrease of costs for preparing to commercialize Oral Paclitaxel as significant pre-launch activities occurred in 2020 and slowed upon receipt of the Complete Response Letter in February 2021.

Interest Income and Interest Expense

Interest income consisted of interest earned on our short-term investments and decreased to $0.2 million from $0.6 million for the six months ended June 30, 2021 and 2020, respectively. Interest expense totaled $10.6 million and $3.2 million for the six months ended June 30, 2021 and 2020, respectively. Interest expense in the current period was incurred from the Senior Credit Agreement with Oaktree and the write-off of deferred debt issuance costs related to the revenue interest financing, while interest expense in the prior period was primarily incurred from debt under a former credit agreement with Perceptive Advisors LLC and its affiliates.      

Loss on extinguishment of debt

We recognized $7.2 million loss on the extinguishment of debt related to the termination of the senior secured loan agreement with Perceptive for the six-months ended June 30, 2020.

Income Tax (Benefit) Expense

For the six months ended June 30, 2021, income tax benefit amounted to $10.9 million, compared to income tax expense of $3.0 million for the same period in 2020. The income tax benefit in the current year is primarily the result of taxable temporary difference due to the deferred tax liability recognized for the indefinite lived intangible assets acquired in connection with the acquisition of Kuur’s IPR&D. This taxable temporary difference is considered a source of taxable income to support the realization of deferred tax assets from the acquirer which resulted in a reversal of our valuation allowance. The income tax expense in the prior year was primarily attributable to foreign income tax withholdings on our revenue earned under our out-license arrangements.

Liquidity and Capital Resources

Capital Resources

Since our inception, we have incurred net losses and negative cash flows from our operations. Substantially all of our losses have resulted from funding our R&D programs, SG&A costs associated with our operations, and the development of our specialty drug operations in our Commercial Platform and 503B operations and the investment we made in our pre-launch activities in anticipation of commercializing our proprietary drugs. We incurred net losses of $60.2 million and $60.1 million for the six months ended June 30, 2021 and 2020, respectively. As of June 30, 2021, we had an accumulated deficit of $773.0 million. Our operating activities used $69.1 million and $70.1 million of cash during the six months ended June 30, 2021 and 2020, respectively. We intend to continue to advance our various clinical and pre-clinical programs which we expect will lead to continuous cash outflow of R&D costs and though we have reduced our planned expenditures in 2021 while there is uncertainty around the best path forward for Oral Paclitaxel, we expect to increase our investments in commercialization activities for our proprietary drugs, if approved. In addition, we can provide no assurance that our funding requirements to diversify our product portfolio for specialty drug products in our Commercial Platform and 503B operations will decline in the future. Our principal sources of liquidity as of June 30, 2021 were cash and cash equivalents totaling $76.9 million, restricted cash of $16.5 million, held in a controlled bank account in connection with the Senior Credit Agreement with Oaktree, and short-term investments totaling $53.3 million, which are generally high-quality investment grade corporate debt securities.

Our obligations under the Senior Credit Agreement are guaranteed by us and certain of our existing domestic subsidiaries and subsequently acquired or organized subsidiaries subject to certain exceptions. Our obligations under the Senior Credit Agreement and the related guarantees thereunder are secured, subject to customary permitted liens and other agreed upon exceptions, by (i) a pledge of all of the equity interests of our direct subsidiaries, and (ii) a perfected security interest in all of our tangible and intangible assets.

37


 

The Senior Credit Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness, and dividends and other distributions, subject to certain exceptions, including specific exceptions with respect to product commercialization and development activities. In addition, the Senior Credit Agreement contains certain financial covenants, including, among other things, maintenance of minimum liquidity and a minimum revenue test, measured quarterly until the last day of the second consecutive fiscal quarter where the consolidated leverage ratio does not exceed 4.5 to 1, provided that thereafter we cannot allow our consolidated leverage ratio to exceed 4.5 to 1, measured quarterly. Failure of the Company to comply with the financial covenants will result in an event of default, subject to certain cure rights of the Company. At June 30, 2021, we were in compliance with all applicable covenants.

Outlook

We have borrowed and, in the future, may borrow additional capital from institutional and commercial banking sources to fund future growth, including pursuant to the Senior Credit Agreement, or potentially pursuant to new arrangements with different lenders. We may borrow additional funds on terms that may include restrictive covenants, including covenants that further restrict the operation of our business, liens on assets, high effective interest rates, financial performance covenants and repayment provisions that reduce cash resources and limit future access to capital markets. In addition, we expect to continue to opportunistically seek access to the equity capital markets to support our development efforts and operations. To the extent that we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution. To the extent that we raise additional funds through collaboration or partnering arrangements, we may be required to relinquish some of our rights to our technologies or rights to market and sell our products in certain geographies, grant licenses on terms that are not favorable to us, or issue equity that may be substantially dilutive to our stockholders.

As of June 30, 2021, we had cash and cash equivalents of $76.9 million, restricted cash of $16.5 million, and short-term investments of $53.3 million. We believe that the existing cash and cash equivalents, restricted cash, and short-term investments will enable us to meet our current operational liquidity needs and fund operations into the fourth quarter of 2022. The Company’s estimates are based on relevant conditions that are known and reasonably knowable at the date of these consolidated financial statements being available for issuance and are subject to change due to changes in business, industry or macroeconomic conditions. Further, we do not expect to have access to additional capital under the Senior Credit Agreement and the Revenue Interest Financing Agreement, and will need to find alternative sources of financing until such time as Oral Paclitaxel is approved or will need to renegotiate these arrangements. We have based these estimates on assumptions that may prove to be wrong, and it could spend the available financial resources much faster than expected and need to raise additional funds sooner than anticipated.

We have made certain changes to our budgeted expenses in light of the CRL for Oral Paclitaxel we received in February 2021 and the Type A meeting with the FDA, including curtailing commercialization expenses and investing in additional products for our specialty pharma business. However, we expect that our expenses will increase as we continue to fund clinical and preclinical development of our research programs by advancing certain product candidates in our pipeline, including product candidates on our Orascovery and Src Kinase Inhibition technology platforms, our cell therapy programs, our specialty drug products, working capital and other general corporate purposes. Capital expenditure at both Dunkirk and Sintaho facilities will continue to grow and be significant as we build out both plants to manufacture drugs including 503B, Tirbanibulin APIs and injectable products. We have based our estimates on assumptions that might prove to be wrong and our estimates are also subject to change depending on the outcome of our discussions with the FDA with respect to Oral Paclitaxel, and we might use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our drug candidates, we are unable to accurately estimate the amounts of increased capital outlays and operating expenditures necessary to complete the development and commercialization of our drug candidates.

Our future capital requirements will depend on many factors, some or all of which may be impacted by the COVID-19 pandemic, including:

 

Our ability to generate revenue and profits from our Commercial Platform or otherwise;

 

The costs, timing and outcome of regulatory reviews and approvals;

 

Progress of our drug candidates to progress through clinical and regulatory development successfully;

38


 

 

 

The initiation, progress, timing, costs and results of nonclinical studies and clinical trials for our other programs and potential drug candidates;

 

The costs of preparing our Commercial Platform for the commercialization of our proprietary drugs;

 

The costs of construction and fit-out of planned drug at both Dunkirk and API manufacturing facilities;

 

The number and characteristics of the drug candidates we pursue;

 

The costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our IP rights and defending IP related claims;

 

The extent to which we acquire or in-license other products and technologies; and

 

Our ability to maintain and establish collaboration arrangements on favorable terms, if at all.

Until we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements, and government grants. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect rights of holders of common stock. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends and might require the issuance of warrants, which could potentially dilute the ownership interest of holders of common stock. If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we might have to relinquish valuable rights to our technologies, future revenue streams or research programs or to grant licenses on terms that might not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we might be required to delay, limit, reduce, or terminate our product development or future commercialization efforts or grant rights to develop and market products or drug candidates that we would otherwise prefer to develop and market ourselves.

Cash Flows

The following table provides information regarding our cash flows for the six months ended June 30, 2021 and 2020:

 

 

 

Six Months Ended June 30

 

 

 

2021

 

 

2020

 

 

 

(in thousands)

 

Net cash used in operating activities

 

$

(69,090

)

 

$

(70,068

)

Net cash provided by investing activities

 

 

74,728

 

 

 

18,125

 

Net cash provided by financing activities

 

 

1,449

 

 

 

41,573

 

Net effect of foreign exchange rate changes

 

 

267

 

 

 

(403

)

Net increase (decrease) in cash, cash equivalents,

   and restricted cash

 

$

7,354

 

 

$

(10,773

)

 

Net Cash Used in Operating Activities

The use of cash in our operating activities resulted primarily from our net loss adjusted for non-cash charges and changes in components of working capital. The primary use of our cash in the periods presented was to fund our R&D, regulatory and other clinical trial costs, drug licensing costs, inventory purchases, pre-launch commercialization activities, and other expenditures related to sales, marketing and administration.

Net cash used in operating activities decreased $1.0 million, or 1%, for the six months ended June 30, 2021.

Net cash used in operating activities was $69.1 million for the six months ended June 30, 2021. This resulted primarily from our net loss of $60.2 million, adjusted for non-cash charges of $9.7 million, non-cash income benefit of $10.9 million related to the reversal of our valuation allowance on our deferred tax assets to offset the deferred tax liability assumed in connection with the acquisition of Kuur’s IPR&D, and by cash used by our operating assets and liabilities of $7.6 million. Our operating assets decreased $1.4 million for accounts receivable mainly related to the decreased sales of specialty products, increased $0.3 million in prepaid expenses and other assets, and increased $0.9 million for inventory of all drug products. Our operating liabilities decreased by $7.8 million mainly due to a decrease in accrued selling fees and royalties on our specialty drugs and a decrease in accrued costs for product launch, partially offset by an increase in accrued license fees and accrued interest. Our net non-cash charges during the six months ended June 30, 2021 consisted of $4.7 million of stock-based compensation expense, $2.5 million depreciation and amortization expense, $1.5 million amortization of debt discount, $0.6 million write-off of deferred debt issuance costs related to the revenue interest financing, and $0.4 million change in fair value of contingent consideration.

39


 

Net cash used in operating activities was $70.1 million for the six months ended June 30, 2020. This resulted primarily from our net loss of $60.8 million, adjusted for non-cash charges of $15.4 million, and by cash used by our operating assets and liabilities of $24.7 million. Our operating assets increased $21.9 million for accounts receivable mainly related to the contract asset recognized from license revenue in the current period and the increased sales of specialty products during the six-months ended June 30, 2020, and decreased by $1.5 million for inventory of all drug products, and $1.0 for prepaids and other assets. Our operating liabilities increased by $5.3 million mainly due to an increase in accrued selling costs and rebates, and an increase in accrued wages and benefits, and other operating liabilities. Our net non-cash charges during the six months ended June 30, 2020 primarily consisted of $7.2 million of loss on extinguishment of debt, $5.3 million of stock-based compensation expense, and $2.1 million depreciation and amortization expense. 

Net Cash Provided by Investing Activities

Net cash provided by investing activities was $74.7 million for the six months ended June 30, 2021, compared to $18.1 million in the six months ended June 30, 2020. The difference was primarily due to more cash being provided by the sales and maturities of short-term investments and cash acquired from the acquisition of Kuur, partially offset by an increase in cash paid for property and equipment at our API and Dunkirk facilities and cash paid for in-licenses fees related to our specialty drugs during the six months ended June 30, 2021.

Net Cash Provided by Financing Activities

Net cash provided by financing activities was $1.4 million for the six months ended June 30, 2021, which consisted of $1.6 million from the exercise of stock options, and $0.8 million proceeds from the issuance of debt, partially offset by $1.0 million repayment of debt and finance lease obligations.

Net cash provided by financing activities was $41.6 million for the six months ended June 30, 2020, which primarily consisted of $94.2 million from the draw downs of debt from our credit facility with Oaktree and $1.0 million to fund our new API plant in China, $5.8 million from the issuance of warrants to Oaktree, and $0.8 million from the exercise of stock options and sale of common stock, partially offset by $54.1 million repayment of Perceptive debt and $6.1 million issuance costs of the new Oaktree debt.

Contractual Obligations

A summary of our contractual obligations as of June 30, 2021 is as follows:

 

 

 

Payments Due by Period

 

 

 

 

 

 

 

Within

1 Year

 

 

1 to 3

years

 

 

3 to 5

years

 

 

More than

5 years

 

 

Total Amounts

Committed

 

 

 

(in thousands)

 

Operating leases

 

$

3,307

 

 

$

4,434

 

 

$

2,663

 

 

$

289

 

 

$

10,693

 

Long-term debt

 

 

4,360

 

 

 

25,507

 

 

 

132,868

 

 

 

 

 

 

162,735

 

Finance lease obligations

 

 

382

 

 

 

492

 

 

 

60

 

 

 

 

 

 

934

 

Licensing fees

 

 

3,066

 

 

 

800

 

 

 

 

 

 

 

 

 

3,866

 

 

 

$

11,115

 

 

$

31,233

 

 

$

135,591

 

 

$

289

 

 

$

178,228

 

 

40


 

 

The above table includes the Company’s operating leases and the amounts committed under those leases by each location: (1) the rental of our global headquarters in the Conventus Center for Collaborative Medicine in Buffalo, NY; (2) the rental of our R&D facility in the IC Development Centre in Hong Kong; (3) the rental of the Commercial Platform headquarters in Chicago, IL; (4) the rental of our clinical research headquarters in Cranford, NJ; (5) the rental of our clinical data management center in Taipei, Taiwan; (6) the rental of eight facilities of our contract research organization throughout Latin America; (7) the rental of our Global Supply Chain distribution office in Houston, TX; (8) the rental of our Global Supply Chain API manufacturing facility in Chongqing, China; and (9) the rental of other facilities and equipment located mainly in Buffalo, NY.

The long-term debt is comprised of (1) the principal and fees related to the three tranches drawn on our Senior Credit Agreement with Oaktree; (2) our credit arrangement with Chongqing Maliu Riverside Development and Investment Co., LTD; and (3) our mortgage assumed in connection with the acquisition of CDE.

The finance lease obligations represent the lease of various equipment for our facilities in and near Buffalo, NY.

The license fee obligations are due in connection with our in-licensing arrangements for certain of the Commercial Platform’s specialty products.

Off-Balance Sheet Arrangements

We do not maintain any off-balance sheet partnerships, arrangements, or other relationships with unconsolidated entities or others, often referred to as structured finance or special purpose entities, which are established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.

Critical Accounting Policies and Significant Judgments and Estimates

Our condensed consolidated financial statements are prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, costs and expenses, and related disclosures. These estimates form the basis for judgments we make about the carrying values of our assets and liabilities, which are not readily apparent from other sources. We base our estimates and judgments on historical experience and on various other assumptions that we believe are reasonable under the circumstances. On an ongoing basis, we evaluate our estimates and assumptions. Our actual results may differ from these estimates under different assumptions or conditions.

We believe that the assumptions and estimates associated with R&D expenses, chargebacks, stock-based compensation and inventory reserves have the most significant impact on our condensed consolidated financial statements. Therefore, we consider these to be our critical accounting policies and estimates.

Business Acquisitions

The Company accounts for acquired businesses using the acquisition method of accounting, which requires that assets acquired and liabilities assumed be recognized at their estimated fair values as of the acquisition date. Identifiable amortizing intangible assets are recorded on the consolidated balance sheet at fair value and amortized over their estimated useful lives. Acquisition-related costs are expensed as incurred. Any excess of the consideration transferred over the estimated fair values of the net assets acquired is recorded as goodwill. 

Contingent Consideration

Contingent consideration arising from a business acquisition is included as part of the purchase price and is recorded at fair value as of the acquisition date. Subsequent to the acquisition date, the Company remeasures contingent consideration arrangements at fair value at each reporting period until the contingency is resolved. The changes in fair value are recognized within selling, general, and administrative expenses in the Company’s consolidated statement of operations and comprehensive loss. Changes in fair values reflect new information about the likelihood of the payment of the contingent consideration and the passage of time.     

Recent Accounting Pronouncements

In the normal course of business, we evaluate all new accounting pronouncements issued by the FASB, the SEC, or other authoritative accounting bodies to determine the potential impact they may have on our condensed consolidated financial statements.

41


 

Item 3. Quantitative and Qualitative Disclosures about Market Risk.

Foreign Currency Exchange Risk

A significant portion of our business is located outside the United States and, as a result, we generate revenue and incur expenses denominated in currencies other than the U.S. dollar, a majority of which is denominated in Chinese Renminbi (“RMB”). In the six months ended June 30, 2021 and 2020, approximately 0% and 1%, respectively, of our sales, excluding intercompany sales, were denominated in foreign currencies. As a result, our revenue can be impacted by fluctuations in foreign currency exchange rates. We expect that foreign currencies will represent a lower percentage of our sales in the future due to the anticipated growth of our U.S. business. Our international selling, marketing, and administrative costs related to these sales are largely denominated in the same foreign currencies, which somewhat mitigates our foreign currency exchange risk rate exposure.

Currency Convertibility Risk

A portion of our revenues and expenses, and a portion of our assets and liabilities are denominated in RMB. The People’s Republic of China (“PRC”) government uses a single rate of exchange as quoted daily by the People’s Bank of China, (“PBOC”). The PRC imposes a number of procedural requirements that limit the ability to readily convert RMB into U.S. dollars or other foreign currencies. All foreign exchange transactions continue to take place either through the PBOC or other banks authorized to buy and sell foreign currencies at the exchange rates quoted by the PBOC. Approvals of foreign currency payments by the PBOC or other institutions require submitting a payment application form together with suppliers’ invoices, shipping documents and signed contracts.

Additionally, the value of the RMB is subject to changes in PRC central government policies and international economic and political developments affecting supply and demand in the PRC foreign exchange trading system market.

Interest Rate Sensitivity

We had cash, cash equivalents, restricted cash, and short-term investments of $146.7 million as of June 30, 2021. Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of U.S. interest rates. However, because of the short-term nature of the instruments in our portfolio, a sudden change in U.S. market interest rates is not expected to have a material impact on our condensed consolidated financial condition or results of operations. We do not believe that our cash or cash equivalents have significant risk of default or illiquidity.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and Board Chairman (Principal Executive Officer) and our Chief Financial Officer (Principal Financial and Accounting Officer), evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2021. The term “disclosure controls and procedures,” as defined in Rule 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by the company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well-designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June 30, 2021, our Chief Executive Officer and Board Chairman (Principal Executive Officer) and our Chief Financial Officer (Principal Financial and Accounting Officer) concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

On May 4, 2021, the Company entered into the Merger Agreement with Kuur Therapeutics, Inc., a Delaware corporation (“Kuur”) whereby it acquired 100% of the outstanding shares of Kuur.  Under the terms of the Merger Agreement, the Company’s wholly owned subsidiary, Athenex Pharmaceuticals LLC, a Delaware limited liability company, merged with and into Kuur, with Kuur surviving as a wholly owned subsidiary of the Company.  We are currently integrating Kuur into our operations and internal control processes and, pursuant to the Securities and Exchange Commission staff interpretative guidance that assessment of a recently acquired business may be omitted from the scope of an assessment for a period not to exceed one year from the date of acquisition, the scope of our assessment of our internal controls over financial reporting at June 30, 2021 does not include Kuur.

Changes in Internal Control over Financial Reporting

Except for internal controls related to integration activities associated with our acquisition of Kuur, there were no changes in the Company's internal controls over financial reporting during the fiscal quarter ended June 30, 2021, that have materially affected, or are reasonably likely to materially affect, the Company's internal controls over financial reporting.

42


 

PART II—OTHER INFORMATION

Securities Litigation

Following our receipt of the CRL in February 2021 and the subsequent decline of the market price of the Company’s common stock, two purported securities class action lawsuits were filed in the U.S. District Court for the Western District of New York on March 3, 2021 and March 22, 2021, respectively, against the Company and certain members of its management team seeking to recover damages for alleged violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.

The complaints generally allege that between August 7, 2019 and February 26, 2021 (the purported class period), the Company and the individual defendants made materially false and misleading statements regarding the Company's business in connection with the Company’s development of Oral Paclitaxel for the treatment of metastatic breast cancer and the likelihood of FDA approval, and that the plaintiffs suffered losses when the Company’s stock price dropped after its announcement on February 26, 2021 regarding receipt of the CRL. The complaints seek class certification, damages, fees, costs, and expenses. Motions to appoint a lead plaintiff and consolidate the two cases were fully briefed as of May 17, 2021, and are now pending before the court. The defendants expect that the court will issue an order consolidating these two lawsuits and appointing a lead plaintiff in the coming months. Additional similar lawsuits might be filed. The Company and the individual defendants believe that the claims in these lawsuits are without merit, and the Company has not recorded a liability related to this shareholder class action lawsuit as the risk of loss is remote. The Company and the individual defendants intend to vigorously defend against these claims but there can be no assurances as to the outcome.

Shareholder Derivative Lawsuit

On June 3, 2021, a shareholder derivative lawsuit was filed in the United States District Court for the District of Delaware by Timothy J. Wonnell, allegedly on behalf of the Company, that piggy-backs on the securities class actions referenced above.  The complaint names Johnson Lau, Rudolf Kwan, Timothy Cook, and members of the Board as defendants, and generally alleges that they caused or failed to prevent the securities law violations asserted in the securities class actions. The Company and the individual defendants believe the claims are without merit, and the Company has not recorded a liability related to this lawsuit as the risk of loss is remote. The Company and the individual defendants intend to vigorously defend against these claims but there can be no assurances as to the outcome.

Item 1A. Risk Factors.

For a discussion of the Company’s potential risks or uncertainties, please see: (i) “Part I—Item 1A—Risk Factors” and “Part II—Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 filed with the SEC; (ii) “Part II—Item 1A—Risk Factors” and “Part I—Item 2—Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 filed with the SEC; and (iii) the additional risks described below.

We face litigation and legal proceedings and, while we cannot predict the outcomes of such proceedings and other contingencies with certainty, some of these outcomes could adversely affect our business and financial condition. 

Following our receipt of the CRL in February 2021 and the subsequent decline of the market price of the Company’s common stock, two purported class action lawsuits were filed in the U.S. District Court for the Western District of New York on March 3, 2021 and March 22, 2021, respectively, against the Company and certain members of its management team. Defending against these and any future lawsuits and legal proceedings may involve significant expense, be disruptive to our business operations and divert our management's attention and resources. Negative publicity surrounding such legal proceedings may also harm our reputation, our stock price, and adversely impact our business and financial condition.

Further, we cannot predict with certainty the outcomes of these legal proceedings. The outcome of some of these legal proceeding could require us to take, or refrain from taking, actions which could negatively affect our operations or could require us to pay substantial amounts of money adversely affecting our financial condition and results of operations.

The resurgence of COVID-19 in India and other countries where we source supplies may create supply chain risk and disruption risks.

The recent surge of COVID-19 cases in India during the first quarter and continuing throughout the second quarter, a country where we source supplies and maintain partnerships that are key to our generics business, including API, presents business and supply chain disruption risks for the Company to the extent the virus is not able to be contained, there is widespread sickness and disruptions on operations and also in the event state governments in India impose additional lockdowns, restrictions on the operations of businesses and other containment measures to combat the spread of the virus. The scope and impact of any such measures is not yet

43


 

known and will depend on a number of factors, including the ultimate spread and severity of the outbreaks in India and the scope, duration and impact of containment measures on individuals and businesses. If our partners in India experience significant or extended disruptions to their business due to COVID-19, it could result in substantial supply shortages and harm our generics business, as well as our overall financial condition and results of operations.

The Kuur acquisition will increase our capital requirements and failure to successfully integrate Kuur’s business and operations may adversely affect the combined Company’s future results.

We believe that the acquisition of Kuur will result in certain benefits, including certain cost synergies, drive product innovations, and operational efficiencies. However, to realize these anticipated benefits, the businesses of will depend on the Company’s ability to successfully integrate Kuur’s business. We may fail to realize the anticipated benefits of the acquisition in our expected time frame, if at all, for a variety of reasons and the acquisition subjects the Company to a number of additional risks, including the following:

 

Increased operating expenses and cash requirements;

 

The assumption of indebtedness or contingent liabilities ;

 

The issuance of additional equity securities upon the achievement of milestones in the Merger Agreement which would result in additional dilution;

 

Assimilation of operations, intellectual property, products, and product candidates of Kuur, including difficulties associated with integrating new personnel;

 

The diversion of financial and managerial resources from our existing product programs and initiatives as we focus efforts on the integration Kuur’s business;

 

Retention of key employees, the loss of key personnel, and uncertainties in our ability to maintain key business relationships of the acquired business;

 

Risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and regulatory approvals;

 

Our inability to generate revenue from acquired intellectual property, technology, and/or products sufficient to meet our objectives or even to offset the associated transaction and maintenance costs;

 

Risk of conducting research and development activities in new therapeutic areas or treatment modalities in which we have little to no experience; and

 

Successfully combining and integrating the acquired business into our existing business to fully realize the benefits of such acquisition.

The integration may result in additional and unforeseen expenses or delays. If Athenex is not able to successfully integrate Kuur’s business and operations, or if there are delays in combining the businesses, the anticipated benefits of the Merger may not be realized fully or at all or may take longer to realize than expected.

Our access to additional capital under the Senior Credit Agreement, Sagard Revenue Interest Financing Agreement and our out-licensing agreements is dependent on the fulfillment of certain conditions, where applicable, and achievement of certain milestones, some of which may be difficult to achieve in the near term, if at all.

Under our senior secured loan agreement, dated June 19, 2020 and related securities agreements with Oaktree Fund Administration, LLC, as administrative agent, and the lenders party thereto (the “Senior Credit Agreement”), the Revenue Interest Financing Agreement entered into with Sagard on August 4, 2020 (the “Revenue Interest Financing Agreement”)  and our out-licensing arrangements, our ability to access additional capital is dependent on our ability to achieve various regulatory and commercial milestones related to our Oral Paclitaxel program, and there is substantial uncertainty whether we will be able to achieve such milestones. Our Senior Credit Agreement provides that we must meet funding conditions related to the approval and commercialization of Oral Paclitaxel to draw down the remaining $75.0 million of commitments under Senior Credit Agreement. Each of the Senior Credit Agreement and the Revenue Interest Financing Agreement entered into with Sagard on August 4, 2020 (the “Revenue Interest Financing Agreement”) also require bringdowns of various representations and warranties as a condition to funding and our access to funding under the Revenue Interest Financing Agreement is dependent on the approval of Oral Paclitaxel. The Revenue Interest Financing Agreement also provides Sagard with a termination right in the event we do not receive a marketing authorization for Oral Paclitaxel by December 31, 2021. Given that the FDA is requiring us to complete an additional clinical trial, there is a substantial likelihood that we will not be able to receive FDA approval by this date, the agreement will be subject to Sagard’s right of termination and we will generally not be able to access additional funds under our financing arrangements until we receive FDA approval of Oral Paclitaxel.

44


 

Further, in the event we do not meet the funding conditions and/or achieve the various commercial and regulatory milestones in our out-licensing agreements, in which case we will need to raise additional capital and can provide no assurances that we will be able to do so when needed or on acceptable terms. In the event we are unable to access additional capital we would be forced to delay, reduce or eliminate our research and drug development programs or commercialization efforts. In addition, the failure to meet these conditions and milestones would have broader implications on the value and prospects of our Company and could impair our ability to raise such additional necessary capital, grow our business, retain key employees and continue our operations.

The FDA may require a trial design that is cost prohibitive to our ability to commercialize Oral Paclitaxel for MBC.

During the second quarter of 2021, the Company held a Type A meeting with the FDA in response to its CRL regarding the Company’s NDA for Oral Paclitaxel. The Company’s ability to potentially commercialize Oral Paclitaxel for the treatment of metastatic breast cancer, and the timing of such potential commercialization, is dependent on our ability to reach an agreement with the FDA on the path forward for the program, the requirements and progress of a potential new clinical study, the Company’s resubmission of its NDA, ultimate FDA approval, and potentially additional capital. The FDA may require a trial design that will be cost prohibitive or significantly delay any FDA approval for MBC such that we decide not to continue our efforts to commercialize Oral Paclitaxel for this indication, which could have materially and adversely impact our prospects. For additional information, please see “Financial Statements—Note 1—Company and Nature of Business”.

Manufacturing risks, including our inability to manufacture API used in the clinical trials of our proprietary product candidates could adversely affect our ability to commercialize our products and product candidates.

Our business strategy depends on our ability to manufacture API in sufficient quantities and on a timely basis so as to meet our needs to manufacture our product candidates for our clinical trials and to meet consumer demand for our products, while adhering to product quality standards, complying with regulatory requirements and managing manufacturing costs. We are subject to numerous risks relating to our manufacturing capabilities, including:

 

Our inability to manufacture API and clinical products in sufficient quantities to meet the needs of our clinical trials or to commercialize our products;

 

Our inability to manufacture API in the event our manufacturing facilities’ operations, including those at our Taihao API facility, are suspended indefinitely or terminated due to events beyond our control;

 

Our inability to secure product components in a timely manner, in sufficient quantities or on commercially reasonable terms;

 

Our failure to increase production of products to meet demand;

 

Our inability to modify production lines to enable us to efficiently produce future products or implement changes in current products in response to regulatory requirements;

 

Difficulty identifying and qualifying alternative suppliers for components in a timely manner and

 

Potential damage to or destruction of our manufacturing equipment or manufacturing facility.

In addition, we conduct manufacturing operations at our facilities in Chongqing, China to manufacture API. As a result, our business is subject to risks associated with those facilities  in particular and doing business in China generally, including:

 

The possibility of our operations at our Taihao API facility being suspended indefinitely or terminated by an order of the local government due to events beyond our control;

 

The impact of the ongoing COVID-19 pandemic on our operations in China;

 

The possibility that the costs of continuing to build out and maintain the new Sintaho API facility in Chongqing exceed the revenue we are able to generate from manufacturing API at the facility;

 

Adverse political and economic conditions, particularly those negatively affecting the trade relationship between the U.S. and China;

 

Trade protection measures, such as tariff increases, and import and export licensing and control requirements;

 

Potentially negative consequences from changes in tax laws;

 

Difficulties associated with the Chinese legal system, including increased costs and uncertainties associated with enforcing contractual

 

Obligations in China;

45


 

 

 

Potentially lower protection of intellectual property rights;

 

Unexpected or unfavorable changes in regulatory requirements;

 

Possible patient or physician preferences for more established pharmaceutical products and medical devices manufactured in the U.S.; and

 

Difficulties in managing foreign relationships and operations generally.

We recently received verbal notice from the DEMC in July 2021 that we will be required to terminate the production activities at our Taihao API facility at the end 2021. We are engaging in a dialogue with the DEMC but if we are unable to continue production activities, we will need to incur significant capital expenditures to move production lines, including that of our tirbanibulin API, to our Sintaho API facility, and we may experience supply chain issues as a result which could impair our ability to meet our supply obligations to our partners.

These risks are likely to be exacerbated by our limited experience with our current products and manufacturing processes. If, as we expect, our need for API increases, or demand for our products increase, we will have to invest additional resources to purchase components, hire and train employees and enhance our manufacturing processes and may have to use alternate suppliers of API to meet our needs. If we fail to increase our production capacity efficiently, our sales may not increase in line with our forecasts and our operating margins could fluctuate or decline. Any of these factors may affect our ability to manufacture our product and could reduce our revenues and profitability.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

On May 4, 2021 we consummated the acquisition of Kuur, and in connection with such acquisition we issued in a private placement: (i) 14,228,066 shares of common stock of the Company to the stockholders of Kuur, valued at $52,786,124 based on a per share price of $3.71; and (ii) 1,373,601 shares of common stock of the Company to certain key employees and certain directors of Kuur valued at $5,645,500 based on a per share price of $4.11. The shares were issued in reliance upon the exemption under Section 4(a)(2) of the Securities Act. For additional information, please see “Part I, Item 1, Note 5—Business Combination.”

Item 3. Defaults Upon Senior Securities.

Not applicable.

Item 4. Mine Safety Disclosures.

Not applicable

Item 5. Other Information.

None.

46


 

Item 6. Exhibits.

The exhibits filed or furnished as part of this Quarterly Report on Form 10-Q are set forth below.

 

 

 

 

 

 

Incorporated by Reference

(Unless Otherwise Indicated)

Exhibit Number

 

Exhibit Title

 

Form

 

File

 

Exhibit

 

Filing Date

 

 

 

 

 

 

 

 

 

 

 

  10.1

 

Agreement and Plan of Merger, by and among Athenex, Inc., Athenex Pharmaceuticals LLC, Kuur Therapeutics, Inc., the holders of the shares of Series C Preferred Stock or Series C-1 Preferred Stock (the “Merger Stockholders”), Kevin S. Boyle, Sr., Kurt C. Gunter and Melinda K. Lackey (the “Key Employees”), the members of the Company Board (as defined therein) (the “Independent Company Directors”) and Shareholder Representative Services LLC, solely as representative, agent and attorney-in-fact of the Merger Stockholders, Key Employees and Individual Company Directors, dated May 4, 2021.

 

Form 8-K

 

001-38112

 

10.1

 

May 5, 2021

 

 

 

 

 

 

 

 

 

 

 

  10.2

 

Lock-Up Agreement between Athenex, Inc. and Touchstone Innovations Businesses LLP (IP Group), dated May 4, 2021.

 

Form 8-K

 

001-38112

 

10.2

 

May 5, 2021

 

 

 

 

 

 

 

 

 

 

 

  10.3

 

Lock-Up Agreement between Athenex, Inc. and each of the parties named therein, dated as of May 4, 2021.

 

Form 8-K

 

001-38112

 

10.3

 

May 5, 2021

 

 

 

 

 

 

 

 

 

 

 

  10.4

 

First Amendment and Limited Waiver to Credit and Guaranty Agreement between Athenex and Oaktree, dated June 3, 2021.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

  10.5

 

Amended and Restated Co-Development Agreement between Baylor College of Medicine and Kuur Therapeutics Limited, dated February 28, 2020.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

  10.6

 

Amended and Restated Exclusive License and Option Agreement between Baylor College of Medicine and Kuur Therapeutics Limited, dated February 28, 2020.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

  31.1

 

Certification of the Chief Executive Officer and Board Chairman (Principal Executive Officer) pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

  31.2

 

Certification of the Chief Financial Officer (Principal Financial and Accounting Officer) pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

  32.1

 

Certification of the Chief Executive Officer and Board Chairman (Principal Executive Officer) and the Chief Financial Officer (Principal Financial and Accounting Officer) pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

101.INS

 

Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

101.SCH

 

Inline XBRL Taxonomy Extension Schema Document.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

101.CAL

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

101.DEF

 

Inline XBRL Taxonomy Extension Definition Linkbase Document.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

101.LAB

 

Inline XBRL Taxonomy Extension Label Linkbase Document.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

101.PRE

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document.

 

 

 

 

Filed herewith

 

 

 

 

 

 

 

 

 

 

 

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

Filed herewith

 

47


 

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

Athenex, Inc.

 

 

Date: August 5, 2021

By:

 

/s/ Johnson Y.N. Lau

 

 

 

Chief Executive Officer and Board Chairman

(Principal Executive Officer)

 

 

 

 

Date: August 5, 2021

By:

 

/s/ Randoll Sze

 

 

 

Chief Financial Officer

(Principal Financial and Accounting Officer)

 

48

 

Execution Version

Exhibit 10.4

 

 

FIRST AMENDMENT AND LIMITED WAIVER TO CREDIT AND GUARANTY AGREEMENT

 

THIS FIRST AMENDMENT AND LIMITED WAIVER TO CREDIT AND GUARANTY AGREEMENT (this “Amendment”), dated as of June 3, 2021 (the “Amendment Effective Date”), is made by and among ATHENEX, INC., a Delaware corporation (the “Borrower”), the Lenders party hereto and OAKTREE FUND ADMINISTRATION, LLC, as administrative agent for the Lenders (in such capacity, the “Administrative Agent”).

WHEREAS, the parties hereto are party to that certain Credit and Guaranty Agreement, dated as of June 19, 2020 (as amended, restated or modified from time to time, the “Credit Agreement”) by and among the Borrower, the Guarantors party thereto from time to time, the Lenders party thereto from time to time, and the Administrative Agent.

WHEREAS, the Borrower has requested that the Majority Lenders and the Administrative Agent agree to make certain amendments to the Credit Agreement, subject to the terms and conditions contained herein.

WHEREAS, pursuant to Section 8.12 of the Credit Agreement, the Borrower is required to cause each New Subsidiary (as defined below) to become Subsidiary Guarantors under the Credit Agreement and Grantors under the Security Agreement by June 3, 2021, and the Borrower has requested that the Majority Lenders and Administrative Agent extend such time period to July 3, 2021.

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereto agree as follows.

SECTION 1Capitalized Terms. All capitalized terms used in this Amendment (including in the recitals hereof) and not otherwise defined herein shall have the meanings assigned to them in the Credit Agreement.

SECTION 2Amendment to the Loan Agreement. The Credit Agreement is hereby amended as set forth in Annex A attached hereto such that all of the newly inserted double-underlined text (indicated textually in the same manner as the following examples: double-underlined text and double-underlined text) and any formatting changes attached hereto shall be deemed to be inserted in the text of the Credit Agreement, and all of the deleted stricken text (indicated textually in the same manner as the following examples: stricken text and stricken text) shall be deemed to be deleted from the text of the Credit Agreement.

SECTION 3Limited Waiver. The Borrower shall promptly, and in any event no later than July 3, 2021, (a) cause Kuur Therapeutics, Inc., a Delaware corporation and Cell Medica, Inc., a Texas corporation (collectively, the “New Subsidiaries”), to become Subsidiary Guarantors under the Credit Agreement and Grantors under the Security Agreement and (b) take such other actions with respect thereto as may be required pursuant to the Loan Documents, in each case on the terms and subject to the provisions of the Loan Documents, including Section 8.12 of the Credit Agreement.

SECTION 4Effectiveness. This Amendment shall become effective only upon the satisfaction or waiver by the Majority Lenders of the following conditions precedent (the date of such satisfaction or waiver of the following conditions being referred herein as the “Amendment No. 1 Effective Date”):

(a)Each of the Borrower and the Majority Lenders shall have executed this Amendment and the Administrative Agent shall have received a fully executed copy of this Amendment.

(b)The representations and warranties of the Borrower set out in Section 5 below shall be true and correct on and as of the Amendment No. 1 Effective Date, except for any representation or warranty expressly stated to be made as of a specific date, in which case such representation or warranty shall be true and correct as of such specific date.

(c)The Administrative Agent and the Lenders shall have received on or prior to the Amendment No. 1 Effective Date reimbursement or payment of documented costs, fees and expenses incurred by the Administrative Agent and the Lenders (including the reasonable legal fees and out-of-pocket expenses of Sullivan & Cromwell LLP,

 

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as outside counsel to the Administrative Agent) in connection with the preparation, negotiation, execution and delivery of this Amendment that are required to be reimbursed or paid pursuant to Section 14.03(a) of the Credit Agreement.

SECTION 5Representations and Warranties.

(a)Power and Authority. The Borrower has full power, authority and legal right to enter into and perform its obligations under this Amendment and the other Loan Documents to which it is a party.

(b)Authorization; Enforceability. The execution of this Amendment and performance hereunder are within the Borrower’s corporate or other organizational powers and have been duly authorized by all necessary corporate or other organizational action including, if required, approval by all necessary holders of Equity Interests. This Amendment has been duly executed and delivered by the Borrower and constitutes a legal, valid and binding obligation of the Borrower, enforceable against the Borrower in accordance with its terms, except as such enforceability may be limited by (i) bankruptcy, insolvency, reorganization, moratorium or similar laws of general applicability affecting the enforcement of creditors’ rights and (ii) the application of general principles of equity (regardless of whether such enforceability is considered in a proceeding in equity or at law).

(c)Governmental and Other Approvals; No Conflicts. None of the execution, delivery and performance by the Borrower of the Amendment (i) requires any Governmental Approval of, registration or filing with, or any other action by, any Governmental Authority or any other Person, except for such as have been obtained or made and are in full force and effect, (ii) will violate (1) any Law, (2) any Organic Document of the Borrower or (3) any order of any Governmental Authority, that in the case of clause (ii)(1) or clause (ii)(3), individually or in the aggregate, could reasonably be expected to result in a Material Adverse Effect, (iii) will violate or result in a default under any Material Agreement binding upon the Borrower that, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Effect or (iv) will result in the creation or imposition of any Lien (other than Permitted Liens) on any asset of any Obligor or any of its Subsidiaries.

(d)Representations and Warranties. Except as set forth on the Disclosure Letter, dated as of the date hereof, delivered by the Borrower to the Administrative Agent, the representations and warranties contained in the Credit Agreement and in the other Loan Documents are true and correct in all material respects (or, in the case of any representation or warranty that is qualified by materiality, in all respects) on and as of the date hereof to the same extent as though made on and as of the date hereof, except to the extent such representations and warranties specifically relate to an earlier date, in which case such representations and warranties are true and correct in all material respects (or, in the case of any representation or warranty that is qualified by materiality, in all respects) on and as of such earlier date.

(e)No Default or Event of Default. No event has occurred and is continuing or would result after giving effect to this Amendment that would constitute an Event of Default or a Default.

SECTION 6Miscellaneous.

(a)References Within Loan Documents. On and after the Amendment No.1 Effective Date, each reference in the Credit Agreement to “this Agreement” and the words “hereof,” “herein,” “hereunder,” or words of like import, shall mean and be a reference to the Loan Agreement as amended by Section 2 of this Amendment.

(b)Binding Effect. This Amendment binds and is for the benefit of the successors and permitted assigns of each party.

(c)Limited Waiver. Except as specifically modified above, (i) the Credit Agreement and all other Loan Documents shall remain in full force and effect, and are hereby ratified and confirmed and (ii) the execution, delivery and effectiveness of this Amendment shall not operate as a waiver of any right, power or remedy of the Administrative Agent or the Lenders, nor constitute a waiver of any provision of the Credit Agreement or any of the Loan Documents. None of the Administrative Agent or any Lender is under any obligation to enter into this Amendment. The entering into this Amendment by such parties shall not be deemed to limit or hinder any rights of any such party under the Loan Documents, nor, except as provided in Sections 2 and 3 hereof, shall it be deemed to

 

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create or infer a course of dealing between any such party, on the one hand, and the Borrower, on the other hand, with regard to any provision of the Loan Documents.

(d)Governing Law. THIS AMENDMENT SHALL BE CONSTRUED IN ACCORDANCE WITH AND GOVERNED BY THE LAWS OF THE STATE OF NEW YORK.

(e)Severability of Provisions. Each provision of this Amendment is severable from every other provision in determining the enforceability of any provision.

(f)Counterparts. This Amendment may be executed in any number of counterparts and by different parties on separate counterparts, each of which, when executed and delivered, is an original, and all taken together, constitute one Amendment. Delivery of an executed counterpart of a signature page of this Amendment by facsimile, portable document format (.pdf) or other electronic transmission will be as effective as delivery of a manually executed counterpart hereof.

(g)Loan Documents. This Amendment and the documents related thereto shall constitute Loan Documents.

(h)Electronic Execution of Certain Other Documents. The words “execution,” “execute”, “signed,” “signature,” and words of like import in or related to any document to be signed in connection with this Amendment and the transactions contemplated hereby (including without limitation assignments, assumptions, amendments, waivers and consents) shall be deemed to include electronic signatures, the electronic matching of assignment terms and contract formations on electronic platforms approved by the Administrative Agent, or the keeping of records in electronic form, each of which shall be of the same legal effect, validity or enforceability as a manually executed signature or the use of a paper-based recordkeeping system, as the case may be, to the extent and as provided for in any applicable law, including the Federal Electronic Signatures in Global and National Commerce Act, the New York State Electronic Signatures and Records Act, or any other similar state laws based on the Uniform Electronic Transactions Act.

[Balance of Page Intentionally Left Blank; Signature Pages Follow]

 

 

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IN WITNESS WHEREOF, the parties hereto have duly executed this Amendment, as of the date first above written.

 

BORROWER:

ATHENEX, INC.,

 

 

 

 

a Delaware corporation

 

 

 

 

By:

/s/ Johnson Y.N. Lau

 

Name:

Dr. Johnson Y.N. Lau

 

Title:

Chairman and Chief Executive Officer

 

 

 

 

[Signature Page to First Amendment and Limited Waiver to Credit Agreement]

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ADMINISTRATIVE AGENT:

 

 

OAKTREE FUND ADMINISTRATION, LLC

 

 

By:

Oaktree Capital Management, L.P.

Its:

Managing Member

 

 

 

 

By:

/s/ Jessica Dombroff

Name:

Jessica Dombroff

Title:

Vice President

 

 

 

 

By:

/s/ Brian Price

Name:

Brian Price

Title:

Senior Vice President

 

 

[Signature Page to First Amendment and Limited Waiver to Credit Agreement]

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LENDERS:

 

 

OAKTREE-TCDRS STRATEGIC CREDIT, LLC

 

 

 

 

By:

Oaktree Capital Management, L.P.

Its:

Manager

 

 

 

 

By:

/s/ Jessica Dombroff

Name:

Jessica Dombroff

Title:

Vice President

 

 

 

 

By:

/s/ Brian Price

Name:

Brian Price

Title:

Senior Vice President

 

 

 

 

[Signature Page to First Amendment and Limited Waiver to Credit Agreement]

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EXELON STRATEGIC CREDIT HOLDINGS, LLC

 

 

 

 

By:

Oaktree Capital Management, L.P.

Its:

Manager

 

 

 

 

By:

/s/ Jessica Dombroff

Name:

Jessica Dombroff

Title:

Vice President

 

 

 

 

By:

/s/ Brian Price

Name:

Brian Price

Title:

Senior Vice President

 

 

 

[Signature Page to First Amendment and Limited Waiver to Credit Agreement]

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OAKTREE-NGP STRATEGIC CREDIT, LLC

 

 

 

 

By:

Oaktree Capital Management, L.P.

Its:

Manager

 

 

 

 

By:

/s/ Jessica Dombroff

Name:

Jessica Dombroff

Title:

Vice President

 

 

 

 

By:

/s/ Brian Price

Name:

Brian Price

Title:

Senior Vice President

 

 

[Signature Page to First Amendment and Limited Waiver to Credit Agreement]

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OAKTREE-MINN STRATEGIC CREDIT LLC

 

 

 

 

By:

Oaktree Capital Management, L.P.

Its:

Manager

 

 

 

 

By:

/s/ Jessica Dombroff

Name:

Jessica Dombroff

Title:

Vice President

 

 

 

 

By:

/s/ Brian Price

Name:

Brian Price

Title:

Senior Vice President

 

 

 

[Signature Page to First Amendment and Limited Waiver to Credit Agreement]

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OAKTREE-FORREST MULTI-STRATEGY LLC

 

 

 

 

By:

Oaktree Capital Management, L.P.

Its:

Manager

 

 

 

 

By:

/s/ Jessica Dombroff

Name:

Jessica Dombroff

Title:

Vice President

 

 

 

 

By:

/s/ Brian Price

Name:

Brian Price

Title:

Senior Vice President

 

 

[Signature Page to First Amendment and Limited Waiver to Credit Agreement]

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OAKTREE-TBMR STRATEGIC CREDIT FUND C, LLC

 

 

 

 

By:

Oaktree Capital Management, L.P.

Its:

Manager

 

 

 

 

By:

/s/ Jessica Dombroff

Name:

Jessica Dombroff

Title:

Vice President

 

 

 

 

By:

/s/ Brian Price

Name:

Brian Price

Title:

Senior Vice President

 

 

[Signature Page to First Amendment and Limited Waiver to Credit Agreement]

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OAKTREE-TBMR STRATEGIC CREDIT FUND , LLC

 

 

 

 

By:

Oaktree Capital Management, L.P.

Its:

Manager

 

 

 

 

By:

/s/ Jessica Dombroff

Name:

Jessica Dombroff

Title:

Vice President

 

 

 

 

By:

/s/ Brian Price

Name:

Brian Price

Title:

Senior Vice President

 

 

[Signature Page to First Amendment and Limited Waiver to Credit Agreement]

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OAKTREE-TBMR STRATEGIC CREDIT FUND G, LLC

 

 

 

 

By:

Oaktree Capital Management, L.P.

Its:

Manager

 

 

 

 

By:

/s/ Jessica Dombroff

Name:

Jessica Dombroff

Title:

Vice President

 

 

 

 

By:

/s/ Brian Price

Name:

Brian Price

Title:

Senior Vice President

 

 

 

[Signature Page to First Amendment and Limited Waiver to Credit Agreement]

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OAKTREE-TSE 16 STRATEGIC CREDIT, LLC

 

 

 

 

By:

Oaktree Capital Management, L.P.

Its:

Manager

 

 

 

 

By:

/s/ Jessica Dombroff

Name:

Jessica Dombroff

Title:

Vice President

 

 

 

 

By:

/s/ Brian Price

Name:

Brian Price

Title:

Senior Vice President

 

 

 

[Signature Page to First Amendment and Limited Waiver to Credit Agreement]

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INPRS STRATEGIC CREDIT HOLDINGS, LLC

 

 

 

 

By:

Oaktree Capital Management, L.P.

Its:

Manager

 

 

 

 

By:

/s/ Jessica Dombroff

Name:

Jessica Dombroff

Title:

Vice President

 

 

 

 

By:

/s/ Brian Price

Name:

Brian Price

Title:

Senior Vice President

 

 

 

[Signature Page to First Amendment and Limited Waiver to Credit Agreement]

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OAKTREE HUNTINGTON-GCF INVESTMENT FUND, L.P.

 

 

 

 

By:

Oaktree Huntington-GCF Investment Fund GP, L.P.

Its:

General Partner

 

 

By:

Oaktree Huntingon-GCF Investment Fund GP, LLC

Its:

General Partner

 

 

By:

Oaktree Fund GP I, L.P.

Its:

Managing Member

 

 

 

 

By:

/s/ Jessica Dombroff

Name:

Jessica Dombroff

Title:

Vice President

 

 

 

 

By:

/s/ Brian Price

Name:

Brian Price

Title:

Senior Vice President

 

 

 

[Signature Page to First Amendment and Limited Waiver to Credit Agreement]

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OAKTREE STRATEGIC INCOME II, INC.

 

 

 

 

By:

Oaktree Fund Advisors, LLC

Its:

Investment Advisor

 

 

 

 

By:

/s/ Jessica Dombroff

Name:

Jessica Dombroff

Title:

Vice President

 

 

 

 

By:

/s/ Brian Price

Name:

Brian Price

Title:

Senior Vice President

 

 

 

[Signature Page to First Amendment and Limited Waiver to Credit Agreement]

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OAKTREE SPECIALTY LENDING CORPORATION

 

 

 

 

By:

Oaktree Fund Advisors, LLC

Its:

Investment Advisor

 

 

 

 

By:

/s/ Jessica Dombroff

Name:

Jessica Dombroff

Title:

Vice President

 

 

 

 

By:

/s/ Brian Price

Name:

Brian Price

Title:

Senior Vice President

 

 

 

[Signature Page to First Amendment and Limited Waiver to Credit Agreement]

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OAKTREE STRATEGIC INCOME CORPORATION

 

 

 

 

By:

Oaktree Fund Advisors, LLC

Its:

Investment Advisor

 

 

 

 

By:

/s/ Jessica Dombroff

Name:

Jessica Dombroff

Title:

Vice President

 

 

 

 

By:

/s/ Brian Price

Name:

Brian Price

Title:

Senior Vice President

 

 

 

[Signature Page to First Amendment and Limited Waiver to Credit Agreement]

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OAKTREE GILEAD INVESTMENT FUND, L.P.

 

 

 

 

By:

Oaktree Gilead Investment Fund GP, L.P.

Its:

General Partner

 

 

By:

Oaktree Fund GP, LLC

Its:

General Partner

 

 

By:

Oaktree Fund GP I, L.P.

Its:

Managing Member

 

 

 

 

By:

/s/ Jessica Dombroff

Name:

Jessica Dombroff

Title:

Vice President

 

 

 

 

By:

/s/ Brian Price

Name:

Brian Price

Title:

Senior Vice President

 

 

 

 

 

[Signature Page to First Amendment and Limited Waiver to Credit Agreement]

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Annex A

Conformed Credit Agreement

[See Attached]

 

 

 

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business (other than Liens imposed by ERISA) and (ii) deposits in respect of letters of credit, bank guarantees or similar instruments issued for the account of any Obligor or any Subsidiary in the Ordinary Course supporting obligations of the type set forth in clause (i) above;

provided that no Lien otherwise permitted under any of the foregoing clauses (b), (c), (d), (e) and (g) through (q) of this Section 9.02 shall apply to any Material Intellectual Property, except for (x) Liens securing Indebtedness permitted under clause (o) of this Section 9.02 and (y) Permitted Licenses incurred pursuant to the terms of the definition thereof with the consent of the Administrative Agent if so required pursuant to this Section 9.02.

9.03 Fundamental Changes and Acquisitions. Such Obligor will not, and will not permit any of its Subsidiaries to, (i) enter into any transaction of merger, amalgamation or consolidation, (ii) liquidate, wind up or dissolve itself (or suffer any liquidation or dissolution), (iii) sell or issue any of its Disqualified Equity Interests or (iv) other than Permitted Acquisitions, make any Acquisition or otherwise acquire any business or substantially all the property from, or Equity Interests of, or be a party to any Acquisition of, any Person, except:

(a)the merger, amalgamation or consolidation or liquidation of any (i) Subsidiary with or into any Obligor or Pledged Entity; provided that with respect to any such transaction involving (x) the Borrower, the Borrower must be the surviving or successor entity of such transaction, (y) any other Obligor, such Obligor must be the surviving or successor entity of such transaction (unless such transaction involves more than one Obligor, then an Obligor must be the surviving or successor entity of such transaction) and (z) any Pledged Entity (but not a transaction involving the Borrower or another Obligor, which is subject to clauses (x) and (y) above, respectively), such Pledged Entity must be the surviving or successor entity of such transaction (unless such transaction involves more than one Pledged Entity, then a Pledged Entity must be the surviving or successor entity of such transaction) or (ii) any Subsidiary that is not an Obligor nor a Pledged Entity with or into any other Subsidiary that is not an Obligor nor a Pledged Entity;

(b)the sale, lease, transfer or other disposition by (i) any Subsidiary of any or all of its property (upon voluntary liquidation or otherwise) to any Obligor, (ii) any Subsidiary that is not an Obligor of any or all of its property (upon voluntary liquidation or otherwise) to any Pledged Entity or (iii) any Subsidiary that is neither an Obligor nor a Pledged Entity of any or all of its property (upon voluntary liquidation or otherwise) to any other Subsidiary that is neither an Obligor nor a Pledged Entity; and

(c)the sale, transfer or other disposition of the Equity Interests of (i) any Subsidiary to any Obligor, (ii) any Subsidiary that is not an Obligor to any Pledged Entity or (iii) any Subsidiary that is neither an Obligor nor a Pledged Entity to any other Subsidiary that is neither an Obligor nor a Pledged Entity. ; and

(d)any Obligor may enter into mergers, amalgamations and consolidations to effect Permitted Acquisitions, provided that (i) if any Obligor is party to such transaction, (x) such  Obligor shall be the continuing or surviving entity or (y) other than in the case of the Borrower,  the surviving Person or the acquiring Person shall agree to assume, and shall expressly assume,  all of the obligations of such Obligor hereunder and under the other Loan Documents pursuant to an agreement in form and substance reasonably satisfactory to the Majority Lenders and (ii) such Permitted Acquisitions effected by such merger, consolidation or amalgamation are otherwise  permitted under the Loan Documents without giving effect to this clause (d).

9.04 Lines of Business. Such Obligor will not, and will not permit any of its Subsidiaries to, engage in any business other than the business engaged in on the date hereof by such Persons or a business reasonably related, incidental or complementary thereto or reasonable extensions thereof.

9.05 Investments. Such Obligor will not, and will not permit any of its Subsidiaries to, make, directly or indirectly, or permit to remain outstanding any Investments except:

(a)Investments (but without giving effect to the cash return provision contained in the definition thereof) outstanding on the date hereof and identified in Schedule 9.05 and any renewals, amendments and replacements thereof that do not increase the amount thereof of any such Investment, net of cash returns thereon, or require that any additional Investment be made (unless otherwise permitted hereunder);

 

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(b)operating deposit accounts with banks (or similar deposit-taking institutions) that, in the case maintained by Obligors, are Controlled Accounts;

(c)extensions of credit in the nature of accounts receivable or notes receivable arising from the sales of goods or services in the Ordinary Course;

(d)Permitted Cash Equivalent Investments ;

(e)Investments by an Obligor (i) in another Obligor, (ii) in connection with a Permitted Acquisition, or (iii) in a Subsidiary that is not an Obligor; provided that Investments made pursuant to this clause (iii) shall not exceed an amount permitted under Section 9.01(h);

(f)Investments by a Subsidiary that is not an Obligor in any other Subsidiary that is not an Obligor;

(g)Permitted Hedging Agreements;

(h)Investments consisting of prepaid expenses, negotiable instruments held for collection or deposit, security deposits with utilities, landlords and other like Persons and deposits in connection with workers’ compensation and similar deposits, in each case, made in the Ordinary Course;

(i)employee loans, travel advances and guarantees in accordance with the Borrower’s usual and customary practices with respect thereto (if permitted by applicable Laws) which in the aggregate shall not exceed $2,500,000 outstanding at any time (or the Equivalent Amount in other currencies);

 

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Exhibit 10.5

 

Certain information in this exhibit marked [*] has been excluded from the exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

EXECUTION COPY

CONFIDENTIAL

 

AMENDED AND RESTATED

 

CO-DEVELOPMENT AGREEMENT

 

BY AND BETWEEN

 

BAYLOR COLLEGE OF MEDICINE

 

AND

 

KUUR THERAPEUTICS LIMITED

(f/k/a CELL MEDICA, LTD.)

 

 

 

Original Effective Date: APRIL 29, 2016

 

Restatement Effective Date: FEBRUARY 28, 2020

 

 

 


EXECUTION COPY

CONFIDENTIAL

 

 

Table of Contents

Article I DEFINITIONS AND CONSTRUCTION2

 

1.1

Definitions2

 

Article II BAYLOR RESEARCH AND DEVELOPMENT8

 

2.1

General8

 

 

2.2

Implementation9

 

 

2.3

Administrative Support10

 

 

2.4

Use of Baylor Subdivisions10

 

 

2.5

Compliance10

 

 

2.6

Baylor Enabling Technology11

 

 

2.7

Identification of Future Oncology Inventions and Future Non-Oncology Inventions12

 

 

2.8

SIRAs and SICRAs12

 

 

2.9

Baylor Covenants13

 

 

2.10

Academic Freedom14

 

 

2.11

Use of Funds14

 

Article III CELL MEDICA SUPPORT15

 

3.1

Quarterly R&D Payment15

 

 

3.2

Payment15

 

 

3.3

Taxes16

 

 

3.4

Determination of Annual R&D Commitment for Fourth Fiscal Year and Beyond16

 

 

3.5

Cell Medica Modified NKT Technology17

 

 

3.6

Early R&D Activities17

 

 

3.7

License to Baylor for Early R&D Activities18

 

Article IV JOINT STEERING COMMITTEE18

 

4.1

Purpose18

 

 

4.2

Composition and Payment18

 

 

4.3

Meetings and Voting19

 

 

4.4

Development Plan21

 

 

4.5

Limitations22

 

 

4.6

Termination of JSC22

 

Article V RESEARCH & DEVELOPMENT ACTIVITIES; KEY PERSON22

 

5.1

General22

 

 

5.2

Key Person23

 

 

5.3

Reporting; Data Package24

 

 

5.4

Unperformed Early R&D Activities25

 

 

5.5

Third Party Enabling Technology26

 

Article VI RECORDS AND REGULATORY MATTERS27

 

6.1

Financial Records27

 

 

6.2

Scientific Records27

 

 

6.3

Regulatory Authority Inspections28

 

 

6.4

Regulatory Authority Communications28

 

i


EXECUTION COPY

CONFIDENTIAL

 

 

6.5

Research Misconduct28

 

Article VII OWNERSHIP AND RESERVATION OF RIGHTS29

 

7.1

Baylor29

 

 

7.2

Cell Medica29

 

 

7.3

Joint Property30

 

 

7.4

CREATE Act30

 

Article VIII CONFIDENTIALITY AND NON-DISCLOSURE30

 

8.1

Incorporation of Article XVII of License and Option Agreement30

 

Article IX WARRANTIES AND LIABILITY30

 

9.1

Mutual Representations and Warranties30

 

 

9.2

Baylor Representations and Warranties31

 

 

9.3

Disclaimer31

 

 

9.4

EXCLUSION AND LIMITATION OF LIABILITY31

 

 

9.5

Indemnification32

 

Article X TERM AND TERMINATION33

 

10.1

Term33

 

 

10.2

Termination33

 

 

10.3

Effects of Termination35

 

 

10.4

Survival36

 

Article XI DISPUTE RESOLUTION36

 

11.1

Amicable Resolution36

 

 

11.2

Arbitration36

 

 

11.3

Injunctive Relief37

 

 

11.4

Construction and Jurisdiction38

 

 

11.5

JSC Disputes38

 

Article XII MISCELLANEOUS38

 

12.1

Use of Names38

 

 

12.2

Independent Contractors38

 

 

12.3

Assignment; Change of Control38

 

 

12.4

Contract Interpretation39

 

 

12.5

Entire Agreement39

 

 

12.6

Non-Waiver40

 

 

12.7

Severability40

 

 

12.8

Force Majeure40

 

 

12.9

Notices40

 

 

12.10

Counterparts41

 

 

12.11

Effect of Restatement41

 

 

 

 

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AMENDED AND RESTATED

CO-DEVELOPMENT AGREEMENT

This Amended and Restated Co-Development Agreement (the “Restated Agreement”), effective as of February 28, 2020 (the “Restatement Effective Date”), is by and between (i) Baylor College of Medicine (“Baylor”), a Texas nonprofit corporation having its principal place of business at One Baylor Plaza, Cullen Building, Suite 106A, Houston, Texas 77030, and (ii) Kuur Therapeutics Limited (formerly known as Cell Medica, Ltd.) (Reg. No. 05620555), a private limited company organized under the laws of England and Wales and having a principal place of business at 1 Canal Side Studios, 8-14 St Pancras Way, London, NW1 0QG, United Kingdom (“Cell Medica” or “Kuur”). As of the Restatement Effective Date, this Restated Agreement amends and restates the Co-Development Baylor Agreement enter into by Baylor and Cell Medica dated April 29, 2016, as such agreement has been amended by that certain First Amendment dated July 12, 2017 and that certain Second Amendment dated February 28, 2019 (collectively, the “Original Agreement”).

WHEREAS, Baylor, through the Developer(s) (as defined below), has developed certain proprietary technology, expertise, information, materials and/or know-how related to NKT Cells (as defined below) and certain antigens, each potentially useful for the development of cellular immunotherapies for the treatment of certain human diseases;

WHEREAS, Cell Medica has developed proprietary technology, expertise, information, materials and know-how related to the discovery and development of cellular immunotherapies to treat human diseases and is engaged in the discovery, development and commercialization of such products and other biopharmaceutical products worldwide;

WHEREAS, Baylor and Cell Medica are entering, contemporaneously with this Agreement, into that certain License and Option Agreement of even date hereof (the “License and Option Agreement”) pursuant to which Baylor has granted to Cell Medica certain exclusive rights under the Core Subject Technology (as defined therein) and certain exclusive options to rights under Future Technology (as defined therein), all under the terms set forth in the License and Option Agreement; and

WHEREAS, the Parties now wish to combine their respective technologies and expertise and collaborate in the performance of Early R&D Activities (as defined below) with respect to Licensed Core Products, Core Subject Technology, Future Technology and Future Products, to be conducted as projects under a mutually agreed Development Plan (defined below) in accordance with the terms set forth herein;

WHEREAS, in connection with the January 2020 Transaction, Baylor and Cell Medica now desire to amend and restate certain terms of the Original Agreement in its entirety as set forth in this Restated Agreement;

WHEREAS, Baylor and Cell Medica have also entered, into the License and Option Agreement dated April 29, 2016, as amended by that certain First Amendment dated May 26, 2017, that certain Second Amendment dated December 5, 2017, that

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certain Third Amendment dated May 17, 2018, that certain Fourth Amendment dated December 19, 2018, and that certain Fifth Amendment dated September 27, 2019 (collectively, the Original License and Option Agreement); and

WHEREAS, in connection with the January 2020 Transaction, Baylor and Cell Medica now desire to amend and restate certain terms of the License and Option Agreement in its entirety as set forth in the restated License and Option Agreement which was executed on an even date with the Restated Agreement (the “Restated License and Option Agreement”).

NOW THEREFORE, in consideration of the foregoing premises and the mutual covenants set forth herein, and for good and valuable consideration the sufficiency of which is hereby acknowledged, the Parties, intending to be legally bound hereto, agree as follows.

Article I
DEFINITIONS AND CONSTRUCTION

1.1Definitions. Capitalized terms used herein and not otherwise defined shall have the meaning given in the License and Option Agreement. As used in this Agreement, the following capitalized terms not defined elsewhere (whether used in the singular or plural) shall have their respective meanings as set forth below.

2020 Series A Financing” means the transactions described in clause (a) of the “2020 Transaction” definition in the License and Option Agreement (and any other transactions and agreements in connection therewith), in each case, during 2020 and consummated as of the Restatement Effective Date.

Added Amount” has the meaning set forth in Section 4.4(c)(iii).

Allocated Amounts” means, collectively, that portion of the Annual Oncology Commitment and the Annual Non-Oncology Commitment which has been allocated in the Development Budget to achievement of each specific activity or purpose under the Development Plan and with each specific activity or purpose under the Development Plan having an Allocated Amount.

Amendment Effective Date” shall have the meaning given in the License and Option Agreement.

Annual Non-Oncology Commitment” means, for a given Fiscal Year, the maximum financial obligation of Cell Medica for such Fiscal Year to support Early R&D Activities for Future Non-Oncology Products (if any) and Future Non-Oncology Technology (if any) in connection with this Agreement, as agreed by the Parties in accordance with Section 4.4(c). Subject to Section 4.4(c), the Annual Non-Oncology Commitment for Fiscal Year 2016 shall be [*], provided that (a) such amount will not be included in the Allocated Amounts unless and until Baylor has provided Cell Medica with an acceptable work plan for use of such funds, and Cell Medica has agreed that such work plan is acceptable, such agreement not to be unreasonably withheld, conditioned,

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or delayed, and (b) Cell Medica shall have no obligation to agree to any Annual Non-Oncology Commitment for any Fiscal Year subsequent to 2016 except in its sole and absolute discretion.

Annual Oncology Commitment” means, for a given Fiscal Year, the maximum financial obligation of Cell Medica for such Fiscal Year to support Early R&D Activities for Licensed Core Products, Core Subject Technology, Future Oncology Products (if any), and Future Oncology Technology (if any) in connection with this Agreement, as agreed by the Parties in accordance with Section 4.4(c). The Annual Oncology Commitment for each of the first three (3) Fiscal Years of the Term (i.e., 2016, 2017 and 2018), shall be [*] or such other amount agreed in accordance with Section 4.4(c).

Annual R&D Commitment” means, for each Fiscal Year, the total of the Annual Oncology Commitment and the Annual Non-Oncology Commitment for such Fiscal Year.

Annual R&D Payment” means, for each Fiscal Year, the total of the Allocated Amounts for such Fiscal Year.

Antigen Option” shall have the meaning given in the License and Option Agreement.

Applicable Laws” means all applicable federal, state and local laws, rules, and regulations. Applicable Laws include, without limitation, relevant provisions of the U.S. FD&C Act, GCP, GLP, GMP and Privacy Laws.

Baylor Enabling Technology” means any Technology or Technology Right, other than Core Subject Technology, Future Technology or a Patent Right, that is (a) owned or Controlled by Baylor and (b) reasonably likely to enable earlier and/or more cost-effective (i) completion of one or more of the tasks set forth in the Development Plan (in whole or in part), or (ii) commercialization (including commercial manufacture) of a Licensed Product or a Future Product.

Baylor Target Antigen” shall have the meaning given in the License and Option Agreement.

Business Day” shall have the meaning given in the License and Option Agreement.

Calendar Quarter” means, within each Fiscal Year, the period commencing on July 1 and ending on September 30, commencing on October 1 and ending on December 31, commencing on January 1 and ending on March 31, or commencing on April 1 and ending on June 30, as applicable.

Cell Medica Property” has the meaning given in Section 7.2.

Cell Medica Successor” shall have the meaning given in the License and Option Agreement.

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Change of Control shall have the meaning given in the License and Option Agreement.

Commercial Manufacturing Process” shall mean a GMP-compliant process for making Licensed Products or Future Products for use in clinical trials or commercial sale.

Commercially Reasonable Efforts” means with respect to carrying out specific tasks and obligations of a Party under this Agreement, including research, development, and manufacture, expending reasonable, diligent, good faith and time- and cost-effective efforts and resources to accomplish such task or obligation as such Party (on its own and/or acting through any of its Affiliates, sublicensees or subcontractors) would normally use to accomplish a similar task or obligation under similar circumstances and consistent with the generally acceptable prudent medical, research, and/or business judgment followed by such Party, and comparable to similarly situated entities.

Completion” shall mean, with respect to each Project, the completion of all Early R&D Activities for such Project specified in the Development Plan.

Control”, “Controls” or “Controlled by” shall have the meaning given in the License and Option Agreement.

Core Subject Technology” shall have the meaning given in the License and Option Agreement.

Data Package” means, with respect to a Product, the data package for such Product to be provided by Baylor to Cell Medica at the Completion of such Product’s FIM Study. The specifics of the Data Package for each Product, including the format(s) in which the Data Package shall be provided, shall be set forth in the Development Plan, but each “Data Package” shall contain, at a minimum (a) all data (including anonymized patient level data) and analyses applicable to such Product, and (b) all invention disclosures and a description of all Baylor Patent Rights and Know-How and other Technology Rights relating to such Product (including Baylor Enabling Technology), and all freedom-to-operate analyses in Baylor’s possession or control applicable thereto (it being understood that Baylor shall have no obligation to obtain a freedom-to-operate analysis), in addition to any other elements of such Data Package specified in the Development Plan.

Developers” shall have the meaning given in the License and Option Agreement.

Development Budget” means both (a) the detailed budget for the Allocated Amounts, based on commercially reasonable and documented costs, for execution of all activities under the Development Plan, including, without limitation, the costs of personnel and facilities, allocated overheads, subcontractor amounts and the acquisition of all materials and equipment required for execution of such activities included in the Development Plan whether or not paid to Baylor or other parties, and (b) all Unallocated Amounts to be spent on such activities and/or equipment, if any, as the JSC shall designate under Section 4.4. All such costs must be commercially reasonable and documented and consistent with the Development Plan. The Development Budget

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includes any modifications adopted by the JSC in accordance with Section 4.4. The Development Budget shall consist of (i) Allocated Amounts for execution of specified activities under the Development Plan and accounting for all activities under the Development Plan and (ii) Unallocated Amounts to be spent on such activities and/or equipment as the JSC shall designate under Section 4.4. To the extent a work plan is agreed upon for the Non-Oncology Technology development, it will be included in the overall Development Plan going forward, and the budget for the specific activities to be conducted thereunder shall be included in the Development Budget.

Development Plan” means the written, detailed plan for the Early R&D Activities for the Licensed Products, Licensed Technology, Future Products (if any), and Future Technology (if any) to be conducted during the Development Term, including (a) key development goals, (b) experimental plans, timeline, and workflow for meeting such goals, (c) the Party responsible for conducting or overseeing each activity; (d) performance metrics and success criteria, including go/no-go criteria, (e) a description of any Specific Industrial Research Agreements or Specific Industrial Clinical Research Agreements to be executed including, in each case, the names of the parties thereto, the subject matter of the agreement, and any work or other obligations to be undertaken by such parties, and (f) the Development Budget for the period covered by the Development Plan. The initial Development Plan for the first three Fiscal Years is attached as Schedule 1 hereto and is directed to the Early R&D Activities for the Licensed Core Products and Core Subject Technology.

Development Term” means the period during which the Parties are conducting research and development of the Licensed Products, Licensed Technology, Future Products (if any) and/or Future Technology (if any), either pursuant to this Agreement or any Specific Industrial Research Agreement or Specific Industrial Clinical Research Agreement executed during the Term, whichever is longer.

Early R&D Activities” shall have the meaning given in the License and Option Agreement.

FDA” means the United States Food and Drug Administration.

FD&C Act” means the United States Federal Food, Drug and Cosmetics Act in effect and as amended during the Term and rule and regulations promulgated by FDA thereunder.

Field” shall have the meaning given in the License and Option Agreement.

FIM Study” shall have the meaning given in the License and Option Agreement.

Fiscal Year” means a 12-month period commencing on July 1 and ending on the following June 30. Notwithstanding the foregoing, solely with respect to 2016, “Fiscal Year” means the period commencing on the Effective Date and ending on June 30, 2017.

Future Non-Oncology Invention” shall have the meaning given in the License and Option Agreement.

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Future Oncology Invention shall have the meaning given in the License and Option Agreement.

Future Products” means Future Oncology Products and Future Non-Oncology Products.

Future Technology” means Future Oncology Technology and Future Non-Oncology Technology.

GCP” means the guidelines for good clinical practices promulgated by the FDA, and all federal, state or local laws, rules, regulations and medical and ethical standards applicable to the conduct of human clinical studies.

GLP” means the then-current good laboratory practice standards promulgated by the FDA pursuant to 21 C.F.R. Part 58 or any successor law or regulation.

GMP” means the then-current good manufacturing practices required by the FDA, as set forth in the FD&C Act and the regulations promulgated thereunder, for the manufacture and testing of pharmaceutical materials, as they may be updated from time to time.

Innovation Development Center” means the unit of Baylor’s Office of Research identified by Baylor as the Innovation Development Center.

Joint Steering Committee” or “JSC” means the committee established pursuant to Section 4.1.

Key Person” means (i) Dr. Leonid Metelitsa, (ii) such other Baylor employee(s) identified as a Principal Investigator (including any Co Investigator) for a given Specific Industrial Research Agreement or Specific Industrial Clinical Research Agreements, or (iii) such other Baylor employee(s) nominated by Baylor in accordance with Section 5.2(b)(ii) accepted by Cell Medica in accordance with Section 5.2(b)(iii), and charged with planning, organizing, performing, managing, or directing specific Projects or other activities under the Development Plan.

Know-How” shall have the meaning given in the License and Option Agreement.

Licensed Future Non-Oncology Technology” shall have the meaning given in the License and Option Agreement.

Licensed Future Products” means the Licensed Future Oncology Products (as defined in the License and Option Agreement) and Licensed Future Non-Oncology Products (as defined in the License and Option Agreement).

Licensed Product” shall have the meaning given in the License and Option Agreement.

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Licensed Technology shall have the meaning given in the License and Option Agreement.

Mark” shall have the meaning given in the License and Option Agreement.

Modified NKT” shall have the meaning given in the License and Option Agreement.

Natural Killer T Cell” or “NKT” shall have the meaning given in the License and Option Agreement.

New Antigen” has the meaning given in Section 4.4(d).

NKT CAR Subject Technology” shall have the meaning given in the License and Option Agreement.

NKT Platform Subject Technology” shall have the meaning given in the License and Option Agreement.

Option” means the Future Oncology Option and/or the Future Non-Oncology Option granted to Cell Medica under Article III of the License and Option Agreement.

Outside the Field” shall have the meaning given in the License and Option Agreement.

Party” means either Cell Medica or Baylor, and “Parties” means Cell Medica and Baylor.

Patent Rights” shall have the meaning given in the License and Option Agreement.

Product” means a Licensed Core Product or Future Product.

Privacy Laws” means all applicable state, federal and local laws, rules and regulations with respect to the collection, use, transfer, storage, deletion, processing (both by computer and manually), combination or other use of subject or other personal data as contemplated by applicable data protection or privacy laws of all data relating to any participant in, or applicant wishing to participate in, a clinical trial, including the Health Insurance Portability and Accountability Act of 1996 and the Health Information Technology for Economic and Clinical Health Act of 2009, and their respective implementing regulations.

Project” means, with respect to a specific Product, if any, or aspect of the Core Subject Technology or Future Technology, if any, the Early R&D Activities under the Development Plan for such Product or technology to be conducted hereunder. Each Project shall be set forth as a separate section in the Development Plan.

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Quarterly R&D Payment means, subject to Section 3.1(b), for each Calendar Quarter, the total of the estimated portion of the Allocated Amounts required for the upcoming Calendar Quarter as agreed by the JSC (as provided in Section 4.4) in the Development Plan and Development Budget.

Specific Industrial Clinical Research Agreement” or “SICRA” means an agreement (a) between the Parties or (b) between Cell Medica (and/or its Affiliate) and a Third Party, in each case, to conduct all or a specific clinical trial portion of a Project.

Specific Industrial Research Agreement” or “SIRA” means an agreement (a) between the Parties or (b) between Cell Medica (and/or its Affiliate) and a Third Party, in each case, to conduct all or a specific non-clinical trial portion of a Project.

T Cell” shall have the meaning given in the License and Option Agreement. “Technology” shall have the meaning given in the License and Option Agreement.

Technology Right” shall have the meaning given in the License and Option Agreement.

Term” means the duration of this Agreement from the Effective Date until the date on which the termination of this Agreement becomes effective in accordance with Section 10.2.

Third Party Enabling Technology” means any Technology or Technology Right that is (a) owned or controlled by a Third Party, (b) reasonably likely to enable earlier and/or more cost-effective (i) completion of one or more of tasks set forth in the Development Plan (in whole or in part), or (ii) commercialization of a Licensed Product or Future Product (if any), and (c) not Controlled by a Party or an Affiliate of a Party.

Unallocated Amounts” means collectively, that portion of the Annual Oncology Commitment and the Annual Non-Oncology Commitment not allocated to the achievement of any specific activity or purpose under the Development Plan for the upcoming Fiscal Year, and available to the JSC for allocation during such Fiscal Year. For a given Fiscal Year, the Unallocated Amounts shall equal (a) the sum of ((x) the Annual R&D Commitment for such Fiscal Year; plus (y) any Added Amount for carried over from the immediately prior Fiscal Year), less (b) the total Allocated Amounts for such Fiscal Year (i.e., Unallocated Amount = (Annual R&D Commitment + Added Amount) ̶ Allocated Amounts).

Article II
BAYLOR RESEARCH AND DEVELOPMENT

2.1General. Early R&D Activities of Core Subject Technology, Licensed Core Products, Future Technology (if any) and Future Products (if any) shall be conducted in accordance with the Development Plan under the oversight of the JSC. Notwithstanding anything contained to the contrary in this Agreement or the License and Option Agreement (including anything set forth this Article II), (a) Baylor shall have the worldwide right to be Cell Medica’s exclusive academic partner to conduct all preclinical, IND-

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enabling Early R&D Activities with respect to each Licensed Core Product, Future Oncology Product, and Future Non-Oncology Product (Baylors Exclusive Academic Partner Early R&D Participation Rights); and (b) without limiting Baylors Exclusive Academic Partner Early R&D Participation Rights set out in the foregoing sentence, Cell Medica shall have the right (either itself or through any of its Affiliates or sublicensees or any other Third Parties) to conduct Early R&D Activities (including preclinical activities and to prepare and file IND applications and subsequent services and other activities, such as, for example, activities required to support clinical development with respect to each Licensed Core Product, Future Oncology Product, and Future Non-Oncology Product which is a Distinct Product). If Cell Medica conducts phase I clinical trial activities with respect to a Distinct Product, Baylor will be (unless Baylor notifies Cell Medica that it does not want to be) the lead clinical center, select the chief (lead) investigator and will be entitled to first and last authorship academic credit with respect to such Early R&D Activities, subject to the terms and conditions of this Agreement and the License and Option Agreement (including Section 17.5 therein).

2.2Implementation. Subject to Cell Medica’s payment and Baylor’s receipt of full payment of each Quarterly R&D Payment under Section 3.1, Baylor shall use Commercially Reasonable Efforts to complete the tasks allocated to it under the Development Plan in accordance with the corresponding performance criteria, and timelines therein, and the Development Budget, including:

(a)allocating, managing, and maintaining sufficient and sufficiently equipped space for all work to be performed;

(b)assigning staff with sufficient qualifications and in sufficient numbers for all work to be timely and professionally performed, and ensuring appropriate oversight for such staff;

(c)distributing and reporting all data and results promptly to Cell Medica subject to any applicable Privacy Laws;

(d)executing with Third Parties such Specific Industrial Research Agreements or Specific Industrial Clinical Research Agreements as the JSC, in its discretion, deems appropriate under the Development Plan and monitoring and reporting on such Third Party’s performance under such Specific Industrial Research Agreement or Specific Industrial Clinical Research Agreements;

(e)conducting all Early R&D Activities assigned to it pursuant to the Development Plan; and

(f)disbursing Allocated Amounts in accordance with the Development Plan and Development Budget.

For the avoidance of doubt, nothing in this Agreement shall obligate Baylor to begin, continue, or complete Early R&D Activities if Cell Medica fails to timely deliver to Baylor the Quarterly R&D Payments in accordance with Sections 3.1 and 3.2 and the Development Budget.

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2.3Administrative Support. Each of Baylor and Cell Medica shall designate a Project Manager to act as a project manager for all activities assigned to such Party under the Development Plan, ensure the appropriate management of resources and reporting of progress and results under the Development Plan and assist the JSC in the administration of the Development Plan as it relates to the activities assigned to such Party pursuant to the Development Plan. Each such Project Manager shall be subject to the other Partys approval, such approval not to be unreasonably conditioned, delayed, or withheld. Baylor shall provide such other administrative support as it deems in its discretion to be necessary for implementation of the activities assigned to Baylor under the Development Plan. The salary for each Project Manager and such other administrative support shall be funded from the Quarterly R&D Payments to the extent set forth in the Development Budget.

2.4Use of Baylor Subdivisions. Baylor, at its discretion, may act through its Innovation Development Center and such other subdivision of Baylor as Baylor shall designate to Cell Medica in the Development Plan or other written notice, to fulfill its obligations under Section 2.2. For the avoidance of doubt, each “subdivision of Baylor” as used in the immediately preceding sentence shall be part of Baylor and not an entity legally distinct from Baylor.

2.5Compliance. Each Party shall comply with all Applicable Laws in connection with its performance hereunder, including with respect to any Early R&D Activities. Without limiting the generality of the foregoing, (a) Baylor shall (i) conduct its activities under the Development Plan in accordance with GLP, GMP and GCP and other Applicable Laws, as applicable, including establishing and maintaining a trial master file for any FIM Studies and maintaining adequate records of and appropriately reporting any adverse events, and managing materials, data and results in compliance with Privacy Laws and other Applicable Laws; (ii) obtain institutional review board approvals for all animal and FIM Studies conducted under the Development Plan; (iii) obtain appropriate informed consent documents from all subjects participating in any FIM Studies under the Development Plan or that have provided biological samples for use in connection with the Development Plan as required by Applicable Laws and as necessary to fulfill its obligations under this Agreement and the License and Option Agreement; and (b) Cell Medica shall and shall ensure that its Affiliates (i) conduct their activities under the Development Plan in accordance with GLP, GMP, and GCP, as applicable, including maintaining adequate records of and appropriately reporting any adverse events, and managing materials, data and results in compliance with Privacy Laws and other Applicable Laws; (ii) obtain (and ensure that each Affiliate obtains) institutional review board approvals for all animal and human studies (if any) conducted by Cell Medica or its Affiliates pursuant to the Development Plan; (iii) obtain (and ensure that each Affiliate obtains) appropriate informed consent documents from all subjects participating in any clinical trials conducted by Cell Medica or its Affiliates pursuant to the Development Plan or that have provided biological samples for use in connection with any research or development conducted by Cell Medica or its Affiliates pursuant to the Development Plan as required by Applicable Laws and as necessary to fulfill its obligations under this Agreement.

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2.6Baylor Enabling Technology.

(a)Presentation. Baylor may, at its option and without obligation, identify and present Baylor Enabling Technology to the JSC which it recommends be included or used in connection with one or more Products. If the JSC agrees that such Baylor Enabling Technology is appropriate for use in one or more Projects, Baylor and Cell Medica may negotiate in good faith the commercially reasonable terms for the use of such Baylor Enabling Technology, including the license rights to be granted to Cell Medica for the use of such Baylor Enabling Technology in the use, development and commercialization of Licensed Products and Licensed Technology; provided that neither Party shall be required to agree to any such terms except in its sole and absolute discretion.

(b)Incorporation.

(i)Baylor shall not utilize any Baylor Enabling Technology in connection with any work performed in connection with the Development Plan unless and until the JSC has approved such use and the Parties have agreed on the terms therefor in accordance with Section 2.6(a).

(ii)Notwithstanding the foregoing Section 2.6(b)(i), if Baylor does utilize any Baylor Enabling Technology in connection with such work without such approval and agreement, then Baylor hereby grants to Cell Medica, a non-exclusive license under Baylor’s right, title and interest in such Baylor Enabling Technology Controlled by Baylor in the Field and Outside the Field to the extent necessary for Cell Medica to exercise (and to the same extent as Cell Medica has the right to exercise) its license rights under the License and Option Agreement.

(iii)The license set forth in Section 2.6(b)(ii) shall (1) be sublicenseable through multiple tiers of sublicensees and assignable in connection with a permitted assignment of the License and Option Agreement, (2) survive for so long as the license rights to such Licensed Product or Licensed Technology under the License and Option Agreement continue, (3) be royalty-bearing in accordance with Section 5.13 of the License and Option Agreement if such Baylor Enabling Technology includes the only Valid Claim(s) covering such Licensed Product (but only if Baylor has granted Cell Medica an exclusive license to such Baylor Enabling Technology that includes the only Valid Claim(s) covering such Licensed Product under the License and Option Agreement), and (4) be royalty-free and fully paid up if such Baylor Enabling Technology does not include the only Valid Claim(s) covering such Licensed Product or is not exclusively licensed to Cell Medica under the License and Option Agreement. If all Baylor Enabling Technology utilized by Baylor in breach of Section 2.6(b)(i) that is necessary for Cell Medica to exercise its license rights under the License and Option Agreement is included in the license granted under Section 2.6(b)(ii), then the grant of such license shall be Cell Medica’s sole remedy and relief for any non-compliance with Section 2.6(b)(i). If Cell Medica seeks any further remedy (including a claim for breach), Cell Medica shall have the burden of showing that the license granted in Section 2.6(b)(ii) is not sufficient to exercise its license rights under the License and Option Agreement. For

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the avoidance of doubt, except as otherwise specified above in this Section 2.6(b), nothing in this Section 2.6(b) shall modify or abate any payments otherwise due under the License and Option Agreement.

2.7Identification of Future Oncology Inventions and Future Non-Oncology Inventions. Baylor shall use Commercially Reasonable Efforts to require that its employees and contractors conducting activities under the Development Plan identify and disclose all inventions or other Technology Rights that would constitute Future Oncology Inventions and Future Non-Oncology Inventions, as such upon or promptly after its discovery, in accordance with Baylor’s then-current intellectual property policies or agreements with employees and contractors. Baylor shall notify the Joint Steering Committee of any so identified Future Oncology Inventions and Future Non-Oncology Inventions, upon and after which notice Cell Medica shall be free to exercise its Option with respect thereto in accordance with Sections 3.1 or 3.2, as applicable, of the License and Option Agreement.

2.8SIRAs and SICRAs. Each SIRA and SICRA will be subject to a procurement review process by the JSC whereby Baylor and/or Cell Medica may submit alternatives for the cost-effective and time-efficient execution of the work to be conducted under any such, as applicable, SIRA or SICRA. The JSC will be responsible for awarding the work based on the merits of different proposals received for the procurement of such work. The budget for each SIRA and SICRA shall be a separate line item in the Development Budget, and each SIRA and SICRA shall in turn have one or more line items addressing the various components of the Early R&D Activities to be conducted thereunder.

(a)Each SIRA and SICRA shall be consistent with and subject to the terms and conditions of this Agreement and the License and Option Agreement, unless specifically and expressly agreed otherwise by the Parties. In the event of any conflict between any SIRA or SICRA, on the one hand, and this Agreement or the License and Option Agreement, on the other hand, such SIRA and SICRA shall control, provided that such SIRA or SICRA and all amendments or side agreements thereto have been approved in writing in their respective full and final forms (including all exhibits, appendices and attachments) by Cell Medica.

(b)Cell Medica shall have the right, but not the obligation, to enter into any SIRA or SICRA with a Third Party (but, for clarity, Baylor will not enter into any SIRA or SICRA except with Cell Medica and/or Cell Medica’s Affiliate unless otherwise mutually agreed by the Parties). For each SIRA and SICRA between Cell Medica and a Third Party governing preclinical, IND-enabling Early R&D Activities approved by the JSC: (i) unless otherwise approved by Baylor in writing, such, as applicable, SIRA or SICRA shall name Baylor as an intended third party beneficiary thereof; (ii) Cell Medica shall promptly provide Baylor with a true, accurate and complete copy of each such, as applicable, executed SIRA or SICRA and any amendment(s) and/or side agreement(s) thereto and all material correspondence relating to each such, as applicable, SIRA or SICRA, amendment or side agreement; (iii) such, as applicable, SIRA or SICRA shall require such Third Party to maintain the confidentiality of all data and results generated under such

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agreement in accordance with Article XVII of the License and Option Agreement (subject to Section 17.5 thereof) and to comply with all Applicable Laws, and (iv) regardless of whether or not Baylor is named as an intended third party beneficiary to a SIRA or SICRA, Cell Medica shall require performance measures, including budget and milestones, in such, as applicable, SIRA or SICRA and, upon Baylors request, shall use reasonably diligent efforts to enforce the terms and conditions of any such, as applicable, SIRA or SICRA.

(c)The Parties agree that (i) a Third Party Specific Industrial Research Agreement in the form set forth as Exhibit A-1 hereto shall satisfy the requirements of Sections 2.8(d) and (e); and (ii) a Third Party Specific Industrial Clinical Research Agreement in the form set forth as Exhibit A-2 hereto shall satisfy the requirements of Sections 2.8(d) and (e).

(d)Prior to any SIRA or SICRA being entered into pursuant to Sections 2.8(d) or (e), the Parties shall execute a letter setting forth (i) Baylor’s consent to such, as applicable, SIRA or SICRA to the terms thereof (with the agreed form of such, as applicable, SIRA or SICRA attached as an exhibit), and (ii) the agreement of the Parties as to any other terms applicable to the Parties’ respective rights and obligations with respect to such, as applicable, SIRA or SICRA, including, if and as applicable, audit and inspection rights, approval of alternate investigators and changes to the research plan and budget, patent prosecution and enforcement, exercise of options to intellectual property, indemnification and survival of sublicenses (provided that with regard to each of the foregoing clauses (i) and (ii), such consent and/or agreement by Baylor shall not to be unreasonably withheld, conditioned or delayed).

(e)A breach under one, as applicable, SIRA or SICRA will be deemed to be a breach of any other, as applicable, SIRA or SICRA, but only if and to the extent the acts, omissions, or other circumstances that gave rise to the breach of the one, as applicable, SIRA or SICRA also gives rise to breach of such other, as applicable, SIRA or SICRA.

2.9Baylor Covenants.

(a)Baylor shall not use, during the Development Term, the services of any persons or entities debarred under 21 U.S.C. § 335(a) or 335(b) or any foreign equivalent, nor disqualified as described in 21 CFR 812.119 or foreign equivalent, in any capacity in connection with the performance of its obligations under this Agreement. Baylor shall immediately inform Cell Medica of any debarment or of the commencement of any debarment or like proceedings against Baylor or any individual or entity performing Early R&D Activities during the Development Term.

(b)Baylor shall permit only Baylor employees (except for any contractor that is a party to a valid agreement with Baylor pursuant to which such contractor irrevocably assigns sole ownership of all Technology and Technology Rights arising from any work conducted under the Development Plan and/or any Specific Industrial Research Agreement or Specific Industrial Clinical Research Agreement to which Cell Medica is not

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a party (each, such agreement, a Baylor Contractor Agreement and each such contractor that is party to a Baylor Contractor Agreement, a Baylor Contractor)) to perform any work assigned to or undertaken by Baylor under the Development Plan and any Specific Industrial Research Agreement or Specific Industrial Clinical Research Agreement. Without limiting the generality of the foregoing, Baylor shall not permit any student or visiting personnel to perform any such work unless such student or visiting personnel is also an employee of Baylor or a Baylor Contractor that is a party to a Baylor Contractor Agreement at the time such student or visiting personnel performs such work.

2.10Academic Freedom. Baylor shall retain, and Cell Medica acknowledges that Baylor shall retain complete academic freedom including, without limitation, all rights and freedom, in its sole discretion, (i) to direct and control its activities under the Development Plan (provided that nothing in this subclause (i) will release Baylor from those obligations it has expressly accepted under this Agreement, the Development Plan or any SIRA), (ii) to modify or terminate any activity under the Development Plan if, in Baylor’s reasonable judgment, (1) continuing the activity would jeopardize the health or safety of any patients, healthcare providers to such patients, or Baylor employees who would otherwise be involved in such activities or (2) Baylor otherwise determines that it is obligated under Applicable Laws to discontinue such activity, (iii) to direct, control, operate, begin, continue, and terminate any and all of its activities outside of the Development Plan and subject to Sections 5.2 and 5.4 of this Agreement and Sections 2.4(b) and 3.6 of the License and Option Agreement, including its educational activities, innovative activities, research and development, (v) subject to Section 5.2 of this Agreement, to hire, retain, dismiss, or compensate its innovators, faculty, staff, students, employees, researchers, and/or other members, and (vi) subject to only Article VIII of this Agreement, to publicly disclose, whether through publications (whether or not peer-reviewed), oral presentations, or any other means, any and all research results, data, findings, conclusions, ideas, theories, discoveries, innovations, and other information.

2.11Use of Funds.

(a)Baylor shall apply the payments it receives under this Agreement solely to carry out its activities under the Development Plan and in accordance with the Development Plan and the terms and conditions of this Agreement. Baylor covenants that it shall use reasonable efforts to avoid using any funds obtained from or on behalf of any Third Party that give rights to such Third Party in or to any Licensed Product or Licensed Technology or Future Product or Future Technology (other than a Future Product that has become a Released Product or Future Technology that has become a Released Invention, subject to, but only to the extent permitted in, Section 3.6 of the License and Option Agreement), except to the extent agreed upon by the JSC and/or set forth in a specific line item of the Development Budget approved by the JSC. For clarity, this Section 2.11 will not prevent Baylor from using equipment funded by an unrestricted grant from a Third Party, provided that such Third Party does not acquire any rights, title or interest (including any contingent rights) in or to any Technology or intellectual property or other Technology Rights arising from the use of such equipment.

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(b)Baylor acknowledges that if a Third Party were to acquire Technology Rights in the products or technology developed under this Agreement without Cell Medicas consent, it may be extremely detrimental to Cell Medica and may impair its ability to effectively develop and commercialize products and technology arising from the Development Plan. Promptly following the Effective Date, Baylor shall establish processes and procedures (including regular training) to be provided by Baylor to its staff conducting the Development Plan to prevent such use of such Third Party funds, and Baylor shall comply with such processes and procedures. Baylor shall conduct regular audits, at least annually, to ensure such processes and procedures are being followed and to determine if any modifications to such processes and procedures are advisable. Baylor shall promptly upon becoming aware report to the JSC (i) any violation of such processes and procedures, and (ii) any instance of Third Party funding of any work conducted in connection with the Development Plan that has not been approved by the JSC and through which such Third Party may acquire rights in or to any product or technology being developed under this Agreement. Nothing in this Section 2.11(b) shall relieve Cell Medica from any burden of proof it would otherwise bear to demonstrate actual harm to Cell Medica arising from any use of Third Party funds by Baylor.

Article III
CELL MEDICA SUPPORT

3.1Quarterly R&D Payment.

(a)Payment. Cell Medica shall pay the first Quarterly R&D Payment contemporaneously with its payment of the License Execution Fee pursuant to Section 5.1 of the License and Option Agreement. Thereafter, Cell Medica shall pay Baylor the Quarterly R&D Payment for each Calendar Quarter during the Term not later than 5 PM Central Time on the tenth (10th) Business Day following the commencement of such Calendar Quarter.

(b)True-Up. If at the end of a Fiscal Year, the sum of the Quarterly R&D Payments received by Baylor for such Fiscal Year exceed Baylor’s expenditures on Development Plan activities approved by the JSC in accordance with the Development Budget, Cell Medica shall be entitled to deduct such excess amount from the next Quarterly R&D Payment(s) that otherwise would be due for the Calendar Quarter(s) immediately following the discovery of such overage (each a “True-Up Credit”). If at the end of a Fiscal Year, the sum of the Quarterly R&D Payments received by Baylor for such Fiscal Year are less than Baylor’s expenditures on Development Plan activities approved by the JSC in accordance with the Development Budget, Baylor shall notify Cell Medica of such shortfall and Cell Medica shall pay Baylor within thirty (30) days of such notice the full amount of such shortfall (each a “True-Up Payment”).

3.2Payment. Any monetary payment owed by Cell Medica to Baylor under this Agreement (“Payment”) shall be made in accordance with this Section 3.2 and Section 3.3. Cell Medica shall make any Payment to Baylor at its cost in immediately available indefeasible unconditional funds in U.S. dollar currency without any set-off or deduction (other than as set forth in Section 3.1(b)) in such form or manner as reasonably directed

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by Baylor. A Payment is owed when due and non-cancelable and non-refundable, except as provided in the next sentence of this Section 3.2 or as set forth in Section 5.2(c), Section 5.4(c) or Section 10.3(a). If Baylor fails to perform its obligations with respect to any Early R&D Activities to be supported by a Payment made by Cell Medica and received by Baylor, the unused portion of the Allocated Amount for such Early R&D Activities shall be (i) credited to Cell Medica for any other Projects under the Development Plan that remain uncompleted or, (ii) refunded to Cell Medica if no other Projects remain in progress. Any amount of any Payment that is not received by Baylor when it is due shall accrue interest, from the date it is due until Baylors receipt of such amount in accordance with this Section 3.2, at the rate of the lower of (a) one-and-one-half percent (1.5%) per full or partial calendar month, or (b) the highest enforceable rate of interest under applicable law. All such interest shall be paid simultaneously with the unpaid amount on which such interest accrued.

3.3Taxes. Any Payment shall be made without any deduction, set-off or withholding of any sales, use, excise, value added or other applicable taxes, tariffs or duties, payment of which shall be the sole responsibility of Cell Medica (excluding any applicable taxes based on Baylor’s net income). In the event that such taxes, tariffs or duties are assessed against Baylor, Cell Medica shall reimburse Baylor for any such amounts paid by Baylor or, prior to the payment of such amounts by Baylor, provide Baylor with valid tax exemption certificates with respect thereto.

3.4Determination of Annual R&D Commitment for Fourth Fiscal Year and Beyond. Beginning no later than six (6) months prior to the end of the second Fiscal Year after the commencement of this Agreement (i.e., beginning no later than July 2018), the Parties shall discuss, through the JSC, the recommended Annual Oncology Commitment (and the Annual Non-Oncology Commitment, if any), for the upcoming Fiscal Year based on the then-current Development Plan and associated Development Budget, it being understood that Cell Medica shall at all times remain contractually obligated to fund the amounts set forth in any then-ongoing Specific Industrial Research Agreement and Specific Industrial Clinical Research Agreement. Cell Medica shall consider such recommendation in good faith, and shall have the right, but not the obligation, to accept such Annual Oncology Commitment and Annual Non-Oncology Commitment and shall notify Baylor in writing of its decision to accept or decline such recommendation; provided, however, that if Cell Medica does not accept such recommendation, Baylor shall have the right, but not the obligation, to delay one or more Projects and/or modify the future activities set forth in the Development Plan for which Cell Medica has not committed funding, commensurate with any gap between the payments actually received in accordance with the Development Budget for such Fiscal Year and the Allocated Amounts for such upcoming Fiscal Year. The Parties’ failure to agree on the Annual Oncology Commitment (and the Annual Non-Oncology Commitment, if any) for an upcoming Fiscal Year shall not affect Cell Medica’s obligations to fund any Specific Industrial Research Agreement or Specific Industrial Clinical Research Agreement that is in place as of the beginning of such Fiscal Year in accordance with its terms. After the closing date of the 2020 Series A Financing, commencing on the Restatement Effective Date and continuing thereafter during the Development Term, Cell Medica will invest not less than [*] per calendar year at Baylor to support Early R&D Activities and/or other Product research and development under this Agreement pursuant to the Development Plan and Development Budget, in each case, as determined by the JSC; except that if there is an additional equity investment in Cell Medica in an amount that is more than Twenty-Five Million Dollars ($25,000,000) after the Restatement Effective Date during the remainder of the 2020 calendar year, then in January 2021 and continuing thereafter during the Development Term, instead of investing not less than [*], Cell Medica will invest not less than [*] per calendar year at Baylor to support Early R&D Activities and/or other

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Product research and development under this Agreement pursuant to the Development Plan and Development Budget, in each case, as determined by the JSC and subject to the terms and conditions of this Agreement.

3.5Cell Medica Modified NKT Technology. Cell Medica may, at its option and without obligation, identify and present to the JSC Technology and Technology Rights which (i) are not Third Party Enabling Technology, (ii) are related to Modified NKTs, and (iii) are discovered or acquired by Cell Medica, and which it recommends be used in connection with, or incorporated into, any Project or Licensed Product or Future Product. If the JSC agrees that such Technology and Technology Rights are appropriate for use in one or more Projects, Baylor and Cell Medica may negotiate in good faith the commercially reasonable terms for incorporating such Technology into this Agreement; provided that neither Party shall be required to agree to any such terms except in its sole and absolute discretion.

3.6Early R&D Activities.

(a)Baylor shall have a non-exclusive right to conduct preclinical, IND-enabling Early R&D Activities relating to each Distinct Product (as defined in the License and Option Agreement) that is a Licensed Core Product and/or a Future Product (if any) in accordance with Section 2.6 of the License and Option Agreement and the Development Plan, other than those activities that the JSC has assigned to Cell Medica or that Cell Medica undertakes pursuant to Sections 5.2(c) or 5.4(c) of this Agreement or that Cell Medica has elected to undertake (including as set forth in Section 2.1 of this Agreement), or as otherwise expressly set forth herein or in the License and Option Agreement.

(b)Cell Medica shall have the right, itself and with its Affiliates and Third Parties to conduct Early R&D Activities (including activities relating to and reasonably likely to contribute to the filing of an investigational new drug application (IND) (or foreign equivalent), or to the development of a Commercial Manufacturing Process, or to the design and execution of clinical studies) and, if such development is successful, commercialization, and any and all such other activities, including such activities as are assigned to it by the JSC in accordance with this Agreement.

3.7License to Baylor for Early R&D Activities. Cell Medica hereby grants to Baylor a non-exclusive (subject to Section 3.6), fully paid-up license to use the Cell Medica Property solely to conduct Baylor’s activities under the Development Plan in accordance with this Agreement and the terms of the applicable Specific Industrial

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Research Agreement and Specific Industrial Clinical Research Agreement, in each case, during the Development Term.

Article IV
JOINT STEERING COMMITTEE

4.1Purpose. On or promptly after the Effective Date, the Parties shall appoint members to the Joint Steering Committee (“JSC”) in accordance with Section 4.2. The JSC shall monitor the conduct of the Development Plan (including any activities conducted under a Specific Industrial Research Agreement or Specific Industrial Clinical Research Agreement and the protocols for each pre-clinical and clinical study to be conducted pursuant to the Development Plan), and coordinate the Parties’ co-development efforts, including reviewing and discussing data, information, and results arising from such efforts. The JSC shall also periodically review and at least once per year update the Development Plan and the Development Budget in accordance with this Article IV. The JSC shall only have the authority expressly granted under this Agreement with all other authority reserved to the Parties.

4.2Composition and Payment.

(a)General. The JSC shall consist of eight members, each a “JSC Member” and collectively, “JSC Members,” of which: (i) four members shall be appointed by Cell Medica, and (ii) four members shall be appointed by Baylor. The initial members of the JSC are attached as Exhibit B. However, unless otherwise mutually agreed by the Parties, as of the Amendment Effective Date or thereafter, the JSC shall consist of four JSC Members of which: (i) two members shall be appointed by Cell Medica, and (ii) two members shall be appointed by Baylor. Each Party shall have sole discretion over the appointment of its JSC Members including choice of appointees and length of service of each. Each Party may change its JSC Members by written notice to the other Party. Each Party shall appoint one of its JSC Members to act as a co-chairperson of the JSC and may change its designated co-chairperson from time to time upon written notice to the other Party. The JSC may appoint subcommittees (e.g., a manufacturing subcommittee) and project teams as it sees fit, each of which shall include at least one JSC Member of each Party and shall remain subordinate to the JSC. To the extent any member of a subcommittee or project team has not previously executed a Confidentiality Agreement, such member shall execute a Confidentiality Agreement upon his or her appointment as a member of any subcommittee or project team. The JSC may change its size from time to time by mutual consent of the Parties, provided that the JSC shall consist at all times of an equal number of JSC Members of each Party.

(b)Consultancy Payments. JSC Members who are not employees of Cell Medica may receive consultancy payments for time and reasonable expenses incurred in the exercise of their responsibilities (each, a “Consultancy Payment”), but only as and to the extent expressly provided for and paid from the Development Budget. All Consultancy Payments shall be consistent with the fair market value of such services, and shall be reviewed through a mutually agreed process to ensure that such payments do not provide an improper inducement to the applicable JSC Member or create a conflict

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of interest. Neither Party shall directly pay the other Partys current or past JSC Members for the exercise of their responsibilities on the JSC or for any other consultancy arrangement during the Term. Any change to Consultancy Payments approved by the JSC after the Effective Date shall be subject to veto by (i) one senior executive officer of Baylor to be named by Baylor and (ii) one senior executive officer of Cell Medica to be named by Cell Medica, such veto to be exercised within thirty (30) days of such JSC approval.

(c)Alternate Members. If a JSC Member cannot attend a JSC Meeting, they may nominate an alternate person (such person, a “JSC Alternate Member”) to serve in their capacity at a JSC Meeting via written notice (which notice can be sent by email) to the JSC co-chairpersons prior to the next scheduled JSC Meeting. The JSC Alternate Member’s appointment to the JSC shall be limited to the single JSC Meeting for which notice has been given (unless such written notice specified that such JSC Alternate Member’s appointment to the JSC will cover more than one JSC Meeting). Upon such person’s appointment as a JSC Alternate Member, each such JSC Alternate Member shall execute a written agreement to be bound by the obligations of confidentiality under Article VIII of the Co-Development Agreement.

4.3Meetings and Voting.

(a)Meetings. The JSC shall meet no less than four times per Fiscal Year on March 15, June 15, September 15, and December 15, or such other dates as unanimously agreed by the JSC, each a “JSC Meeting.” Each JSC Meeting shall be conducted at a specific location or remotely, including by videoconference, teleconference or any other method as may be agreed by the JSC Members beforehand. Unless otherwise agreed by the Parties in writing, all information disclosed, discussed, and/or exchanged during a JSC Meeting shall be Confidential Information in accordance with Article VIII and each JSC Member shall execute an agreement to be bound by the obligations of confidentiality under Article VIII, the form of such agreement to be mutually agreed by the Parties. The co-chairpersons shall jointly prepare the agenda for each JSC meeting and shall circulate reasonably detailed minutes for each JSC meeting within fifteen (15) days following such meeting.

(b)Voting. Voting shall occur solely during JSC Meetings or Interim Voting Meetings (Section 4.3(e)) at which at least one representative for each Party shall be present or actively participating remotely for a meeting of the JSC to take place and for any decision to be submitted to a vote (and all current JSC Members or JSC Alternate Member(s) are present or actively participating remotely, with any vacancies being disregarded for such quorum purposes). Each Party shall have collectively among its JSC Members (including any JSC Alternate Member(s)) one vote per issue upon which a vote is taken by the JSC as required or otherwise permitted under this Agreement, and if a decision of the JSC is required under this Agreement, the Parties shall endeavor to reach such decision by consensus.

(c)Resolution of Impasses. If a vote is taken, but is not unanimous (i.e., there is a deadlock), the JSC shall strive in good faith for the next fifteen (15) days

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to resolve such issue. If, after such fifteen (15)-day period, the JSC cannot reach consensus on such issue, then the JSC, may, if the JSC Members agree to consult within the next thirty (30) days with an external advisor for non-binding advice related to the issue upon which such vote was taken. The expense for any external advisor shall be born equally by the Parties. If the JSC still cannot reach consensus on such issue after receiving advice from the external advisor, or the JSC cannot agree to seek such advice during such thirty (30) day period, or the JSC elects, in its discretion, to forego acquiring such advice from an external advisor, the JSC shall refer the matter to one senior executive officer of Baylor not serving as a current JSC Member to be named by Baylor and one senior executive officer of Cell Medica not serving as a current JSC Member to be named by Cell Medica, who shall meet within thirty (30) days of the referral of such matter to such officers. Together, such senior officers shall have complete and sole authority to resolve the matter; provided, however, if the Parties respective senior officers have not reached consensus on such matter (i.e., there is a deadlock) and such matter relates to any product that has completed a FIM Study, then Cell Medica shall have the final decision-making authority with respect to such matter.

(d)Non-Member Attendance. Each Party may from time to time invite a reasonable number of participants, in addition to its JSC Members, to attend the JSC meetings in a non-voting capacity; provided that if either Party intends to have any Third Party (including any consultant) attend such a meeting, such Party shall provide prior written notice (which notice can be sent by email) to the other Party and shall ensure that such Third Party is bound by confidentiality and non-use obligations consistent with the terms of this Agreement.

(e)Interim Voting Meetings. The JSC may determine to meet via electronic or telephonic correspondence and vote on matters requiring action by the JSC during the interim period between regularly scheduled JSC Meetings (an “Interim Voting Meeting”). Any such Interim Voting Meeting shall take place via emailed notice to all JSC Members. The JSC co-chairpersons shall agree to call any Interim Voting Meeting prior to engaging the remaining JSC Members. Once the need to call an Interim Voting Meeting has been agreed by the JSC co-chairpersons, information on the matter requiring attention and voting by the JSC shall be distributed by emailed notice to the entire JSC Members. JSC Members will be provided with a deadline (which shall be a minimum of five (5) Business Days) by which they must communicate their vote to the JSC co-chairpersons in writing. Each Party shall have collectively among its JSC Members (including any JSC Alternate Member(s)) one vote per issue upon which a vote is taken during an electronic Interim Voting Meeting by the JSC as required or otherwise permitted under this Agreement, and if a decision of the JSC is required under this Agreement, the Parties shall endeavor to reach such decision by consensus. Any and all information disclosed, discussed, or exchanged during the course of such an electronic Interim Voting Meeting shall be Confidential Information in accordance with Article VIII. One of the co-chairpersons shall circulate the outcome of the issue to all JSC Members in writing within twenty-four (24) hours of the voting deadline. The matter requiring an Interim Voting Meeting shall be documented and incorporated into the minutes of the next regularly scheduled JSC meeting.

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4.4Development Plan.

(a)Development Plan Progress and Results. At least ten (10) Business Days prior to each scheduled JSC meeting, each Party shall provide the other Party with a report of its current and planned activities and results under the Development Plan. Each Party shall provide the other Party’s JSC Members with such further information regarding such activities and results as they may reasonably request.

(b)Development Plan Review. The JSC shall review the Development Plan at each JSC Meeting for its scientific, medical, technical, and commercial merit in view of developments over at least the then most recent twelve (12) calendar months. The JSC may modify the Development Plan. It is anticipated that the Development Plan shall be updated in accordance with this subsection (b) to address the integration of Future Products (if any) and Future Technology (if any).

(c)Development Budget.

(i)Review and Modification.The JSC shall review the Development Budget at each JSC Meeting for its commercial and fiscal merit in view of the Development Plan and prior budget amounts, actual prior expenditures, market conditions, and planned future activities and expenditures. The JSC may modify the Development Budget (including the Allocated Amounts and Unallocated Amounts), subject to the Annual Oncology Commitment, the Annual Non-Oncology Commitment and the Annual R&D Commitment. For the avoidance of doubt, the JSC has no authority (1) to increase any of the Annual Oncology Commitment, the Annual Non-Oncology Commitment or the Annual R&D Commitment, each of which may only be increased by the written agreement of an authorized officer of Cell Medica or (2) to decrease any of the Annual Oncology Commitment, the Annual Non-Oncology Commitment or the Annual R&D Commitment, each of which may only be decreased by the written agreement of an authorized officer of Baylor.

(ii)Spending Allocated Amounts. Baylor shall be authorized to disburse all Allocated Amounts for expenditures actually incurred and set forth in the then-current Development Budget for activities assigned to Baylor under the Development Plan and Development Budget without further approval by the JSC, subject to the Annual Oncology Commitment, the Annual Non-Oncology Commitment and the Annual R&D Commitment.

(iii)Spending Unallocated Amounts. Either Party (through its JSC Members or otherwise) may present to the JSC a proposal for the use of all or a portion of the Unallocated Amount for the conduct of research and development of Licensed Products, Licensed Technology, Future Products or Future Technology. The Development Plan and Budget shall be amended by the JSC to include the approved activities and associated approved budgeted amounts, and such budgeted amounts shall be included in the Allocated Amounts going forward. Any portion of the Unallocated Amount unspent at the end of a Fiscal Year shall be added to the Unallocated Amount for the next Fiscal Year (the “Added Amount”).

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(iv)Initial Development Budget for Baylor Target Antigens. During the period from the Effective Date through December 31, 2016, the portion of the Development Budget for Modified NKT Products directed to the Baylor Target Antigens shall materially support development of such Modified NKT Products directed to Baylor Target Antigens up to, but not more than, Seven Hundred Fifty Thousand Dollars ($750,000 USD) (the Baylor Target Antigen Limit). The JSC shall not have the authority to approve total spending under the Development Budget for Modified NKT Products directed to any of the Baylor Target Antigens, whether before or after December 31, 2016, in excess of the Baylor Target Antigen Limit unless and until Cell Medica exercises the Antigen Option for one or more Baylor Target Antigens during such period. If, as of December 31, 2016, Cell Medica has not exercised the Antigen Option for any Baylor Target Antigen, then Cell Medica, in its sole discretion, may authorize spending under the Development Budget for Modified NKT Products directed to such Baylor Target Antigen(s) in excess of the Baylor Target Antigen Limit.

4.5Limitations. The JSC shall not, and shall not have the authority to, waive or modify any right or obligation of either Party under this Agreement. Nothing in this Agreement or the License and Option Agreement shall obligate a Party to enter into an agreement with any Third Party and the JSC shall not have the authority to cause, compel or in any way require a Party to enter into an agreement with any Third Party.

4.6Termination of JSC. The JSC shall terminate at the end of the Development Term.

Article V
RESEARCH & DEVELOPMENT ACTIVITIES; KEY PERSON

5.1General. Without, for the avoidance of doubt, limiting Cell Medica’s right to elect to undertake Early R&D Activities as set forth in Section 2.1 of this Agreement, (a) the Parties intend that, to the extent reasonably practicable, all preclinical IND-enabling Early R&D Activities shall be conducted pursuant to Specific Industrial Research Agreements and/or Specific Industrial Clinical Research Agreements; and (b) the Parties intend that all work pursuant to the Development Plan be undertaken in a cost-effective and time-efficient manner, such that, if the JSC agrees that a Third Party is substantially more qualified and equipped to undertake such work, then the work may be outsourced to such Third Party. Either Party shall have right to suggest alternative procurement sources for specific Projects or portions thereof, and the award of such work will be made by the JSC based on an objective review of capabilities and costs for such work.

5.2Key Person.

(a)Time Commitment and Responsibilities. In recognition of each Key Person’s key role in development of Core Subject Technology and Future Technology under the Development Plan, Baylor shall designate such portion of each Key Person’s working hours to be spent directly planning, organizing, performing, managing, or directing the Projects or other activities applicable to such Key Person under the Development Plan or enhancements or modifications thereof or otherwise performing

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research, development, and collaboration activities under this Agreement necessary to timely complete the Projects under the Development Plan. Baylor shall take such commercially reasonable steps as necessary to adapt any of the Key Persons other employment responsibilities to accommodate such designation of working hours. Baylor shall also provide administrative support for each Key Person in accordance with Section 2.3.

(b)Alternate Key Person.

(i)Baylor shall notify Cell Medica in writing within ten (10) days if a Key Person leaves the employment of Baylor or becomes unwilling or unable to fulfill the role assigned to such Key Person under Section 5.2(a)) or the applicable SIRA.

(ii)At its sole discretion, Baylor may include with any notice under Section 5.2(b)(i) the name and qualifications of another Baylor employee of similar rank and experience to take over the role assigned to such Key Person (“Baylor’s Proposed Alternate Key Person”).

(iii)Cell Medica shall have twenty (20) days from its receipt of Baylor’s notice under Section 5.2(b)(ii) to notify Baylor in writing of Cell Medica’s decision to either (1) accept Baylor’s Proposed Alternate Key Person, whereupon Baylor’s Proposed Alternate Key Person shall become the new Key Person, or (2) decline Baylor’s Proposed Alternate Key Person.

(c)Transfer of Development Plan Activities. If Baylor does not propose an Alternate Key Person under Section 5.2(b)(ii) or if Cell Medica declines Baylor’s Proposed Alternate Key Person, the Parties shall meet to discuss in good faith what elements of the Development Plan are likely to be impacted by the Key Person’s withdrawal substantially and negatively (each such element, a “Key Person Negatively Impacted Development Plan Activity”). Cell Medica shall have the right, in its sole discretion, to transfer each Key Person Negatively Impacted Development Plan Activity to another research organization of its choice or to itself (upon transfer, a “Key Person Transferred Development Plan Activity”). Cell Medica may, at its discretion, deduct from the then-current Quarterly R&D Payment(s) the remaining Allocated Amount(s) designated in the Development Budget for each such Key Person Transferred Development Plan Activity, such deduction to be divided equally among the remaining Quarterly R&D Payments for the period over which such Key Person Transferred Development Plan Activity will be conducted. For the avoidance of doubt, Cell Medica shall retain its Option associated with such Key Person Transferred Development Plan Activity following transfer to itself or another research organization.

5.3Reporting; Data Package.

(a)Quarterly Reports. Beginning with the second Calendar Quarter following the Effective Date, within fifteen (15) days from the beginning of each Calendar Quarter, each Party shall provide the other Party with a detailed written report setting forth the Early R&D Activities undertaken by (or overseen by) such Party during the prior

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Calendar Quarter on a Project-by-Project basis, and all data and results therefrom. The reporting Party shall promptly provide such additional information regarding such Early R&D Activities to the other Party as such other Party reasonably requests.

(b)Delivery of Data and Results under Specific Industrial Research Agreements (SIRAs). For Specific Industrial Research Agreements where Baylor is a party thereto, Baylor shall provide to Cell Medica: (i) the data and reports agreed in such Specific Industrial Research Agreement within thirty (30) days of the achievement of the corresponding event or milestone, and (ii) a final report of all data, results and analyses under such Specific Industrial Research Agreement within sixty (60) days of the completion of all work under such Specific Industrial Research Agreement or its earlier termination.

(c)Delivery of Data and Results under Specific Industrial Clinical Research Agreements (SICRAs). For Specific Industrial Clinical Research Agreements where Baylor is a party thereto, Baylor shall provide to Cell Medica: within fifteen (15) days from the beginning of each Calendar Quarter, a detailed written report setting forth the activities undertaken by (or overseen by) Baylor during the prior Calendar Quarter in connection with each Specific Industrial Clinical Research Agreement, and all data and results therefrom (and including all safety, pharmacokinetic, correlative and efficacy data, and formatted to provide both interval and cumulative data), and such additional information regarding such activities undertaken by (or overseen by) Baylor in connection with each Specific Industrial Clinical Research Agreement to Cell Medica, as Cell Medica reasonably requests) (provided, however, that, unless otherwise requested by Cell Medica, the SICRA quarterly reports to be provided under this Section do not need to include data and other information that is available for Cell Medica to access through Baylor’s electronic case report form (referred to by Baylor as “OnCore”) reporting system (the “Oncore Reporting System”) to the extent that Cell Medica can access, download and obtain copies of all such data and other information at any time. Baylor shall ensure that all patient data arising in connection with each such clinical study shall be entered into the OnCore Reporting System within thirty (30) days of each such patient’s visit or Baylor’s receipt of the patient data.

(d)Monthly Clinical Trial Updates. Baylor shall provide to Cell Medica on a monthly basis a short (e.g., less than one page per study) summary for each clinical study that will include an interval and cumulative listing of the number of (1) patients enrolled, (2) products manufactured, (3) patients treated, (4) patients on study, (5) patients withdrawn early, (6) patients completing study, and (7) deaths on study (and such additional information regarding such activities undertaken by (or overseen by) Baylor in connection with each such clinical trial, as Cell Medica reasonably requests). Baylor shall ensure that all patient data arising in connection with each such clinical study shall be entered into the OnCore Reporting System (defined in Section 5.3(b)) within thirty (30) days of each such patient’s visit.

(e)Delivery of Data Package. Within thirty (30) days following the Completion of a FIM Study (with respect to which Baylor conducted activities or provided oversight), or such other time period as the Parties may agree in writing with respect to

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such FIM Study, Baylor shall deliver to Cell Medica the Data Package for such FIM Study, and shall promptly provide to Cell Medica such additional information regarding such FIM Study and Data Package as Cell Medica reasonably requests.

(f)Project Reports, Data and Results Provided to Cell Medica. Without limiting the generality of the foregoing in this Section 5.3, with respect to the reports, data and results to be provided to Cell Medica under this Section 5.3 (or elsewhere in this Agreement) with respect to any Early R&D Activities or otherwise, all such reports, and all data and results from such Early R&D Activities, shall be provided by Baylor to Cell Medica with respect to any Early R&D Activities conducted by (or overseen by) Baylor (and/or under a SIRA or a SICRA where Baylor is a party thereto), including on a Project-by-Project basis, in Baylor’s standard format which shall include, without limitation, methods, results and conclusion sections and such reports should be signed and dated by the investigator and provide sufficient detail such that a trained person with only superficial knowledge of the Project will be able to interpret the data and results. For the avoidance of doubt, Baylor acknowledges and agrees to provide Cell Medica with access to, and copies of, all reports, data and results arising from the Early R&D Activities conducted by (or overseen by) Baylor.

5.4Unperformed Early R&D Activities.

(a)Notice.

(i)Baylor shall notify Cell Medica in writing within thirty (30) days if it determines that it expects to be unable to, or has not performed one or more of its assigned material Early R&D Activities under the then-current Development Plan in accordance with the time frame and other performance metrics for such activity set forth in the Development Plan.

(ii)Cell Medica shall provide written notice to Baylor that Baylor has not performed, or appears reasonably likely to be unable to perform one or more of its assigned Early R&D Activities under the then-current Development Plan in accordance with the time frame and other performance metrics for such activity set forth in the Development Plan.

(iii)For the avoidance of doubt, notice under Section 5.4(a)(i) shall not be required for Baylor’s JSC Members to, nor in any way restrict Baylor’s JSC Members ability to, request, advocate, and vote for changes to the Development Plan.

(iv)Subject to Section 5.4(b), upon Cell Medica’s receipt of such written notice under Section 5.4(a)(i) or Baylor’s receipt of such written notice under Section 5.4(a)(ii) (as applicable), and if Baylor does not cure such failure to Cell Medica’s reasonable satisfaction within 60 days of the earlier of (1) the occurrence of such failure or (2) the date of such notice, Cell Medica shall have the right to transfer solely such material, non-performed Early R&D Activities to another research organization, or to itself. For clarity, the transfer of any Early R&D Activities under this Section 5.4(a)(iv) will not affect any Option granted to Cell Medica under the License and Option Agreement

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associated with such Early R&D Activities or, for clarity, limit Cell Medicas rights under Section 2.1.

(b)Experimental Nature. Cell Medica acknowledges and agrees that Early R&D Activities are experimental in nature and no specific result or experimental end point can be assured. Accordingly, performance of Early R&D Activities without achieving a desired result or experimental end point shall not alone constitute a failure to perform any material Early R&D Activity and shall not give rise to any right to transfer such Early R&D Activities under Section 5.4(a)(iv).

(c)Transfer of Development Plan Activities. Cell Medica shall provide written notice to Baylor if Cell Medica elects to transfer responsibility for any Early R&D Activities under Section 5.4(a)(iv) and, in each case the Parties shall meet within thirty (30) days of such notice to discuss in good faith what elements of the Development Plan are likely to be, or have been, substantially and negatively impacted by Baylor’s nonperformance or non-compliance in part or whole (each such element, a “Negatively Impacted Development Plan Activity”). Cell Medica shall have the right, in its sole discretion, to transfer each Negatively Impacted Development Plan Activity to another research organization of its choice or to itself for completion (upon transfer, a “Transferred Development Plan Activity”). Subsequent Quarterly R&D Payments shall be reduced by any Allocated Amounts for each such Transferred Development Plan Activity for such Calendar Quarter.

5.5Third Party Enabling Technology. Baylor and Cell Medica each shall notify the JSC of any Third Party Enabling Technology identified by it, and which it recommends be used in connection with, or incorporated into, any Project, Licensed Product or Future Product. If the JSC determines that such Third Party Enabling Technology is appropriate for use in the conduct of the Development Plan with respect to a given Project, Licensed Product or Future Product, then Baylor and Cell Medica shall discuss such issue, and determine in good faith which of the Parties is best suited to pursue acquiring such Third Party Enabling Technology and, if an agreement is reached, such Party shall use Commercially Reasonable Efforts to acquire an appropriate license to such Third Party Enabling Technology, with the right to sublicense to the other Party as needed for such other Party to perform its rights and obligations under this Agreement and the License and Option Agreement (each, a “Third Party Enabling License”). The costs (other than royalties) of such Third Party Enabling License that are directly attributable to the conduct of the Development Plan shall be paid from the Annual Oncology Commitment or Annual Non-Oncology Commitment, as applicable. To the extent any royalties are due under such Third Party Enabling License, and such royalties are paid by Cell Medica, it shall have the right to deduct such royalties from the royalties owed to Baylor for the applicable Licensed Product, as and to the extent set forth in Section 5.13 of the License and Option Agreement. For the avoidance of doubt, it shall be reasonable for Baylor to decline to enter into any agreement that would require Baylor to incur out-of-pocket expenses.

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Article VI
RECORDS AND REGULATORY MATTERS

6.1Financial Records.

(a)Records. Baylor shall use Commercially Reasonable Efforts to maintain complete and accurate records relating to its expenditures under the Development Budget, which records shall contain sufficient information to permit Cell Medica to confirm the accuracy of any reports delivered to Cell Medica with respect to the use of such funds and compliance in other respects with this Agreement. Baylor shall retain such records for at least three (3) years following the end of the Fiscal Year to which they pertain.

(b)Audit by Cell Medica. During the Development Term and for a period of two (2) years thereafter, Cell Medica or its representatives, upon reasonable written notice to Baylor, shall have the right, solely at Cell Medica’s expense, no more than once each twelve (12) month period, and only once after the Development Term to inspect, during Baylor’s regular business hours, Baylor’s financial books and records relating to its expenditures under the Development Budget.

6.2Scientific Records.

(a)Records. Baylor shall maintain complete, current and accurate records of all Early R&D Activities conducted by it hereunder and all data and other information, including, without limitation, laboratory notebooks, assay results and equipment readings, resulting from such activities in accordance with Applicable Laws. Such records shall reflect all work done and results achieved in the performance of the Early R&D Activities in good scientific manner appropriate for regulatory and patent purposes. Baylor shall maintain separate laboratory notebooks for all work conducted in connection with the Development Plan.

(b)Audits. During the Development Term and for a period of two (2) years thereafter, Cell Medica or its representatives, upon reasonable written notice to Baylor, shall have the right, solely at Cell Medica’s expense, no more than once each twelve (12) month period, and only once after the Development Term to inspect, during Baylor’s regular business hours, Baylor’s scientific books and records relating to its activities under the Development Plan. During such audit, Baylor will permit Cell Medica’s representatives to audit the work performed pursuant to the Development Plan and the facilities at which such work is conducted, to determine that Baylor is conducting or conducted such work in accordance with the terms and conditions of this Agreement, that the Applicable Laws are being met, and that Baylor is providing adequate facilities and staffing. Cell Medica’s failure to exercise its right to conduct an audit as described in this Section 6.2(b) shall not represent a waiver of any future exercise of this right or of any other rights under this Agreement, nor does it represent acceptance of any conditions past or present that might exist or result from such conditions at Baylor’s facilities.

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(c)Access. During the Development Term and thereafter, Cell Medica or its representatives shall have the right, upon reasonable written notice and during Baylor’s regular business hours, to have access to and make copies of Baylor’s books and records relating to its activities under the Development Plan in support of patent prosecution and defense and regulatory activities relating to the Licensed Products, Future Products, Licensed Technology and Future Technology, provided that if Cell Medica does not exercise its Option with respect to any Future Product or Future Technology, then Cell Medica’s rights under this subsection (c) with respect to such Future Product or Future Technology shall expire contemporaneously with the expiration of such Option.

6.3Regulatory Authority Inspections. If any Regulatory Authority requests access to Baylor’s records, facilities and/or personnel, or conducts an unannounced inspection, in each case relating to the Development Plan or to any Licensed Product, Licensed Technology, Licensed Future Product (if any) or Licensed Future Technology (if any), then Baylor will promptly notify Cell Medica by telephone (including voicemail) within twenty-four (24) hours followed by immediate written confirmation. Cell Medica will have the right to be present at any Regulatory Authority audit or inspection that relates to any Licensed Product, and, if time reasonably permits, to conduct a pre-inspection audit.

6.4Regulatory Authority Communications. Baylor will provide Cell Medica with copies of all written communications received by Baylor from any Regulatory Authority relating to the Development Plan or to any Licensed Product, Licensed Technology, Licensed Future Product (if any) or Future Technology (if any) promptly upon Baylor’s receipt thereof and, for verbal communications, shall provide Cell Medica with a written summary thereof promptly after such verbal communication. Baylor shall contemporaneously provide Cell Medica with a copy of any written communication from Baylor to a Regulatory Authority relating to the Development Plan or to any Licensed Product, Licensed Technology, Future Product or Future Technology. Where Baylor is required or intends to respond to any communication from a Regulatory Authority relating to the Development Plan or to any Licensed Product, Licensed Technology, Future Product or Future Technology, to the extent practicable, Baylor shall provide Cell Medica with a copy of such communication and the proposed response sufficiently in advance of the date that such response is to be submitted, in order to permit Cell Medica to review and comment upon such response. To the extent permitted by Applicable Laws, Baylor may, in its reasonable judgment, incorporate such Cell Medica comments into such response prior to submission.

6.5Research Misconduct. Baylor shall immediately inform Cell Medica upon discovery of any potential misconduct by any individual or entity performing Early R&D Activities.

Article VII
OWNERSHIP AND RESERVATION OF RIGHTS

7.1Baylor. Baylor shall retain and continue to solely own all rights, title and interest in and to all Technology owned or otherwise Controlled by Baylor existing as of

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the Effective Date, and any and all improvements, derivative works, and other derivations of any of the foregoing, and all Technology Rights in or to any of the foregoing, and all Marks and other intellectual property rights discovered, developed, invented, conceived of, reduced to practice or created solely by Baylor employees or contractors working on its behalf in the conduct of the Development Plan (Baylor Property). Baylor covenants that (a) it shall require all such employees and contractors to assign all right, title and interest in all such Technology Rights and other intellectual property rights to Baylor, and (b) ensure that such right, title and interest in all such Technology Rights and other intellectual property rights vest in Baylor. No right or license is or shall be deemed to be granted, expressly or implicitly, to or under any Baylor Property except solely for the licenses expressly granted in Sections 2.1, 2.2, and 2.3 of the License and Option Agreement. Baylor does not assign, transfer, or convey any right, title, interest, ownership, or co-ownership, or grant any lien or similar right, in or to any Baylor Property, or grant any right, claim, or expectation to Cell Medica to any such right, title, interest, ownership, co-ownership, lien, or similar right, or any license other than as expressly set forth in Sections 2.1, 2.2, and 2.3 of the License and Option Agreement, whether expressly or implicitly. If Baylor or any employee or contractor of Baylor owns or acquires an ownership interest in or to any Cell Medica Property in connection with this Agreement, Baylor agrees to assign, transfer, and convey, and Baylor hereby assigns, transfers, and conveys, and Baylor agrees to cause all such employees and contractors to assign, transfer, and convey, to Cell Medica all such interest, without any payment or right to any payment of any kind. Baylor shall, and shall cause such employees and contractors to, execute any document or take any reasonable action as requested by Cell Medica to effect any such assignment.

7.2Cell Medica. Cell Medica shall retain and continue to solely own all rights, title and interest in and to all of the Technology owned or Controlled by Cell Medica existing as of the Effective Date, and any and all improvements, derivative works, and other derivations of any of the foregoing, and all Technology Rights in or to any of the foregoing, and all Marks and other intellectual property rights discovered, developed, invented, conceived of, reduced to practice or created solely by Cell Medica employees or contractors working on its behalf in the conduct of the Development Plan (“Cell Medica Property”). No right or license is or shall be deemed to be granted, expressly or implicitly, to or under any Cell Medica Property except solely for the licenses expressly granted in Section 3.7. Cell Medica does not assign, transfer, or convey any right, title, interest, ownership, or co-ownership, or grant any lien or similar right, in or to any Cell Medica Property, or grant any right, claim, or expectation to Baylor to any such right, title, interest, ownership, co-ownership, lien, or similar right, or any license other than as expressly set forth in Section 3.7, whether expressly or implicitly. If Cell Medica or any employee or contractor of Cell Medica owns or acquires any ownership interest in or to any Baylor Property in connection with this Agreement, Cell Medica agrees to assign, transfer, and convey, and Cell Medica hereby assigns, transfers, and conveys, and Cell Medica agrees to cause all such employees and contractors to assign, transfer, and convey, to Baylor all such interest, without any payment or right to any payment of any kind. Cell Medica shall, and shall cause such employees and contractors to, execute any document or take any reasonable action as requested by Baylor to effect any such assignment.

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7.3Joint Property. The Parties shall jointly own all rights, title and interest in and to any and all improvements, derivative works, and other derivations of any Baylor Technology or Cell Medica Technology and all Marks and other intellectual property rights discovered, developed, invented, conceived of, reduced to practice or created jointly by Cell Medica employees or consultants working on its behalf and Baylor employees or consultants working on its behalf, in each case, in the conduct of the Development Plan (“Joint Property”). Except to the extent either Party is restricted by the licenses and options granted to the other Party under the License and Option Agreement, each Party shall be entitled to practice and exploit the Joint Property without the duty of accounting or seeking consent from the other Party, and each Party hereby consents to any further sublicensing of such Joint Property anywhere in the world, subject to the licenses granted under the License and Option Agreement. Cell Medica shall have the first right, but not the obligation, to file and prosecute patent applications claiming any Joint Property, at its expense and in consultation with Baylor, and Baylor shall cooperate reasonably with Cell Medica in connection therewith.

7.4CREATE Act. It is the Parties’ intention that this Agreement is a “joint research agreement” as that phrase is defined in 35 U.S.C. §102(c) as amended by the Cooperative Research and Technology Enhancement (CREATE) Act, including the provisions of 35 U.S.C. §102(b)(2)(c). The Parties agree to cooperate and to take reasonable actions to maximize the protections available for the Patent Rights covering the Licensed Technology, Future Oncology Technology or Future Non-Oncology Technology under such safe harbor provisions.

Article VIII
CONFIDENTIALITY AND NON-DISCLOSURE

8.1Incorporation of Article XVII of License and Option Agreement. Article XVII of the License and Option Agreement (captioned “Confidentiality and Non-Disclosure”) is hereby incorporated by reference mutatis mutandis into and made a part of this Agreement.

Article IX
WARRANTIES AND LIABILITY

9.1Mutual Representations and Warranties. Each Party represents and warrants to the other Party that it has the authority to enter this Agreement, and the execution, delivery and performance of this Agreement by such Party has been duly and properly authorized by all necessary corporate actions, and this Agreement constitutes the valid and binding obligation of such Party, except as may be subject to applicable bankruptcy, insolvency, reorganization, arrangement or other similar laws relating to or affecting the rights of creditors generally and the availability of equitable remedies.

9.2Baylor Representations and Warranties. Baylor represents and warrants that, as of the Effective Date:

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(a)All Baylor employees and contractors that perform any Early R&D Activities under this Agreement shall be subject to Baylors IP Policy including its obligation to assign all right, title and interest in any intellectual property arising from such Early R&D Activities to Baylor and to protect Confidential Information of Baylor and Cell Medica;

(b)Neither it nor any of its officials or employees have been convicted of a felony in any jurisdiction for conduct relating to the development or approval, including the process for development or approval, of any drug, product or medical device or otherwise relating to the regulation of any drug, product or medical device, including, without limitation, under the FD&C Act; and

(c)It has not been debarred under 21 U.S.C. § 335(a) or 335(b) or any foreign equivalent, nor disqualified as described in 21 CFR 812.119 or foreign equivalent.

9.3Disclaimer. ALL RESULTS OBTAINED UNDER THE DEVELOPMENT PLAN ARE SUPPLIED “AS IS” “WHERE IS,” AND OTHER THAN THE FOREGOING REPRESENTATIONS AND WARRANTIES IN SECTIONS 9.1 AND 9.2, BAYLOR MAKES NO, AND HEREBY DISCLAIMS ALL, WARRANTIES AND REPRESENTATIONS, EXPRESS, IMPLIED, AND STATUTORY, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, USEFULNESS, ANY PARTICULAR RESULT, NON-INFRINGEMENT, TITLE, OR WORKMANSHIP, OR THAT ANY ENFORCEABLE PROPRIETARY RIGHTS WILL ARISE FROM SUCH RESULTS.

9.4EXCLUSION AND LIMITATION OF LIABILITY. EXCEPT FOR ANY OBLIGATION OF INDEMNITY OR BREACH OF, OR DEFAULT UNDER, ANY SUCH OBLIGATION OR Article VIII, AND EXCEPT FOR OR IN CONNECTION WITH ANY INFRINGEMENT OR MISAPPROPRIATION OF ANY OF THE OTHER PARTY’S INTELLECTUAL PROPERTY RIGHTS: (a) IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT, PUNITIVE, SPECIAL, OR LIQUIDATED DAMAGES OF ANY KIND UNDER OR IN CONNECTION WITH ANY ACTION OR DISPUTE UNDER THIS AGREEMENT; AND (b) IF A PARTY IS LIABLE FOR ANY DAMAGES UNDER THIS AGREEMENT, THE TOTAL AND AGGREGATE DAMAGES FOR WHICH SUCH PARTY MAY BE LIABLE UNDER THIS AGREEMENT SHALL BE LIMITED IN THE AGGREGATE TO THE TOTAL AMOUNT OF THE QUARTERLY R&D PAYMENTS PAID BY CELL MEDICA TO BAYLOR UNDER ARTICLE VIII WITHIN TWENTY-FOUR (24) MONTHS PRIOR TO ASSERTING SUCH CLAIM FOR SUCH DAMAGES AND LOSSES. IN NO EVENT SHALL ANY EXCLUSION OR LIMITATION OF LIABILITY EXCLUDE OR LIMIT ANY FEE OR ROYALTY, OR ANY PART THEREOF, THAT IS DUE UNDER THIS AGREEMENT.

9.5Indemnification.

(a)EACH PARTY SHALL NOTIFY THE OTHER OF ANY THIRD PARTY’S CLAIM, LAWSUIT OR OTHER PROCEEDING RELATED TO ANY EARLY R&D ACTIVITIES AND OTHER PERFORMANCE UNDER THIS AGREEMENT.

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(b)CELL MEDICA AGREES THAT IT WILL DEFEND, INDEMNIFY AND HOLD HARMLESS BAYLOR AND ITS AFFILIATES AND THEIR RESPECTIVE FACULTY MEMBERS, SCIENTISTS, RESEARCHERS, EMPLOYEES, STUDENTS, OFFICERS, TRUSTEES AND AGENTS AND EACH OF THEM (THE BAYLOR INDEMNIFIED PARTIES) FROM AND AGAINST, AND SHALL PAY BAYLOR THE MONETARY VALUE OF, ALL LIABILITIES AND LOSSES RELATED TO OR RESULTING FROM, DIRECTLY OR INDIRECTLY, ANY AND ALL THIRD PARTY CLAIMS, CAUSES OF ACTION, LAWSUITS OR OTHER PROCEEDINGS FILED OR OTHERWISE INSTITUTED AGAINST ANY OF THE BAYLOR INDEMNIFIED PARTIES TO THE EXTENT ARISING FROM (I) ANY NEGLIGENCE, RECKLESSNESS OR WILLFUL MISCONDUCT OF CELL MEDICA OR ANY OF ITS AFFILIATES, OR ANY OF THEIR OFFICERS, DIRECTORS, EMPLOYEES, OR AGENTS, IN CONNECTION WITH THIS AGREEMENT (REGARDLESS OF THE EXISTENCE OF, BUT NOT TO THE EXTENT OF, ANY CONTRIBUTORY OR COMPARATIVE NEGLIGENCE OF ANY BAYLOR INDEMNIFIED PARTIES), OR (II) ANY BREACH OF THIS AGREEMENT BY CELL MEDICA (BAYLOR CLAIMS), AND CELL MEDICA WILL ASSUME RESPONSIBILITY FOR ALL COSTS AND EXPENSES RELATED TO SUCH BAYLOR CLAIMS FOR WHICH IT IS OBLIGATED TO INDEMNIFY THE BAYLOR INDEMNIFIED PARTIES PURSUANT TO THIS SECTION 9.5(b), INCLUDING, BUT NOT LIMITED TO, THE PAYMENT OF ALL REASONABLE ATTORNEYS FEES AND COSTS OF LITIGATION OR OTHER DEFENSE; PROVIDED, HOWEVER, THAT THE INDEMNITY UNDER THIS SECTION 9.5(b) DOES NOT APPLY TO THE EXTENT ANY BAYLOR CLAIM ARISES FROM ANY NEGLIGENCE, RECKLESSNESS, OR WILLFUL MISCONDUCT OF A BAYLOR INDEMNIFIED PARTY OR ANY BREACH OF THIS AGREEMENT BY BAYLOR.

(c)BAYLOR AGREES THAT IT WILL DEFEND, INDEMNIFY AND HOLD HARMLESS CELL MEDICA AND ITS AFFILIATES AND THEIR RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES AND AGENTS AND EACH OF THEM (THE “CELL MEDICA INDEMNIFIED PARTIES”) FROM AND AGAINST, AND SHALL PAY CELL MEDICA THE MONETARY VALUE OF, ALL LIABILITIES AND LOSSES RELATED TO OR RESULTING FROM, DIRECTLY OR INDIRECTLY, ANY AND ALL THIRD PARTY CLAIMS, CAUSES OF ACTION, LAWSUITS OR OTHER PROCEEDINGS FILED OR OTHERWISE INSTITUTED AGAINST ANY OF THE CELL MEDICA INDEMNIFIED PARTIES (“CELL MEDICA CLAIMS”) TO THE EXTENT ARISING FROM (I) ANY NEGLIGENCE, RECKLESSNESS OR WILLFUL MISCONDUCT OF BAYLOR OR ANY OF ITS AFFILIATES, OR ANY OF THEIR OFFICERS, DIRECTORS, EMPLOYEES, OR AGENTS, IN CONNECTION WITH THIS AGREEMENT (REGARDLESS OF THE EXISTENCE OF, BUT NOT TO THE EXTENT OF, ANY CONTRIBUTORY OR COMPARATIVE NEGLIGENCE OF ANY CELL MEDICA INDEMNIFIED PARTIES), OR (II) ANY BREACH OF THIS AGREEMENT BY BAYLOR (“CELL MEDICA CLAIMS”), AND BAYLOR WILL ASSUME RESPONSIBILITY FOR ALL COSTS AND EXPENSES RELATED TO SUCH CELL MEDICA CLAIMS FOR WHICH IT IS OBLIGATED TO INDEMNIFY THE CELL MEDICA INDEMNIFIED PARTIES PURSUANT TO THIS SECTION 9.5(c), INCLUDING, BUT NOT LIMITED TO, THE PAYMENT OF ALL REASONABLE ATTORNEYS’ FEES AND COSTS OF LITIGATION OR OTHER DEFENSE; PROVIDED, HOWEVER, THAT THE INDEMNITY UNDER THIS

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SECTION 9.5(c) DOES NOT APPLY TO THE EXTENT ANY CELL MEDICA CLAIM ARISES FROM ANY NEGLIGENCE, RECKLESSNESS, OR WILLFUL MISCONDUCT OF A CELL MEDICA INDEMNIFIED PARTY OR ANY BREACH OF THIS AGREEMENT BY CELL MEDICA.

(d)THE PARTY CLAIMING INDEMNITY UNDER SECTION 9.5(b) (IF BAYLOR OR A BAYLOR INDEMNIFIED PARTY) OR SECTION 9.5(c) (IF CELL MEDICA OR A CELL MEDICA INDEMNIFIED PARTY) (THE “INDEMNITEE”) AGAINST THE OTHER PARTY (CELL MEDICA UNDER SECTION 9.5(b) OR BAYLOR UNDER SECTION 9.5(c)) (THE “INDEMNITOR”) FOR A BAYLOR CLAIM (IF BAYLOR IS THE INDEMNITEE UNDER SECTION 9.5(b)) OR A CELL MEDICA CLAIM (IF CELL MEDICA IS THE INDEMNITEE UNDER SECTION 9.5(c)) (THE “INDEMNIFIED CLAIM”) SHALL NOTIFY THE INDEMNITOR WITHOUT UNDUE DELAY IN WRITING OF ANY INDEMNIFIED CLAIM FOR WHICH IT SEEKS INDEMNITY HEREUNDER AGAINST THE INDEMNITOR AND COOPERATE REASONABLY WITH THE INDEMNITOR AT THE INDEMNITOR’S SOLE COST AND EXPENSE. THE INDEMNITOR SHALL PROMPTLY, AFTER BEING SO NOTIFIED, ASSUME THE DEFENSE OF SUCH INDEMNIFIED CLAIM WITH COUNSEL OF ITS CHOICE THAT IS REASONABLY SATISFACTORY TO THE INDEMNITEE. THE INDEMNITOR SHALL NOT SETTLE ANY INDEMNIFIED CLAIM WITHOUT THE INDEMNITEE’S PRIOR WRITTEN CONSENT UNLESS THE ONLY OBLIGATION AND LIABILITY OF, AND THE ONLY ADVERSE IMPACT ON, THE INDEMNITEE AND ITS INDEMNIFIED PARTIES IS A PAYMENT OBLIGATION INDEMNIFIED IN FULL BY THE INDEMNITOR. SUBJECT TO THE INDEMNITOR’S RIGHT TO CONTROL THE DEFENSE AND SETTLEMENT THEREOF, THE INDEMNITEE MAY PARTICIPATE IN AND OBSERVE THE PROCEEDINGS AT ITS OWN COST AND EXPENSE WITH COUNSEL OF ITS OWN CHOOSING.

Article X
TERM AND TERMINATION

10.1Term. This Agreement shall commence on the Effective Date and shall continue unless and until terminated in accordance with Section 10.2.

10.2Termination. This Agreement shall terminate in accordance with the following provisions, and with the effects set forth in Section 10.3:

(a)This Agreement shall be co-terminus with the License and Option Agreement and shall terminate automatically, without need for any separate notice or action, upon the termination, expiration, or cancellation of the License and Option Agreement (regardless of any continuation or continued effect of any provisions specified therein as surviving the License and Option Agreement’s termination, expiration, or cancellation, and further regardless of any continuation or continued effect of any Specific Industrial Research Agreement or Specific Industrial Clinical Research Agreement), except that to the extent the License and Option Agreement is terminated only in part, with respect to some but not all Licensed Products, this Agreement shall only terminate with respect to such terminated Licensed Products.

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(b)Cell Medica shall have the right to unilaterally terminate this Agreement upon twelve (12) months prior notice, with such termination to be effective no earlier than three (3) years from the Effective Date.

(c)(i) In the event that a Party materially breaches this Agreement, the other Party may terminate this Agreement by giving sixty (60) days’ advance notice in writing of such termination to such breaching Party identifying therein such material breach, which termination shall be effective at the end of such sixty (60) day period unless: (1) such breaching Party has remedied or cured such material breach before the end of such sixty (60) day period, or (2) such other Party has expressly revoked such notice of termination in a written notice of revocation to such breaching Party dispatched prior to the end of before the end of such sixty (60)-day period. However, and notwithstanding the foregoing, Baylor may terminate this Agreement solely with respect to a Distinct Product in the event of a material default or material failure by Cell Medica to perform any of the terms, covenants or provisions of this Agreement, including failure to make timely payment, and including a breach of its obligations under Section 2.6(a) of the License and Option Agreement regarding Baylor’s Exclusive Academic Partner Early R&D Participation Rights (and provided such failure to comply was not due to the fault of Baylor or its employees or agents), with respect to such Distinct Product (a “Product-Related Breach”), unless Cell Medica, within sixty (60) days after delivery of written notice of termination by Baylor identifying such Product-Related Breach, cures such alleged Product-Related Breach.

(i)Notwithstanding Section 10.2(c)(i), if:

(1)(A) the same type of Product-Related Breach has occurred three (3) times or more with regard to such Distinct Product during the immediately preceding twelve (12) months and (B) Baylor has duly notified Cell Medica in writing of each such Product-Related Breach,

(2)but (A) Baylor has not given written notice of termination therefor, or (B) termination of this Agreement with respect to such Product Related Breach has been avoided by cure thereof, and

(3)Baylor can demonstrate that the pattern of such Product-Related Breaches (as cured by Cell Medica) is causing Baylor material and on-going harm,

then Cell Medica shall not have any further right to cure any further Product-Related Breaches.

(ii)The termination of this Agreement with respect to such Distinct Product shall be effective:

(1)at the end of such sixty (60)-day period if Cell Medica has the right to cure such Product-Related Breach and such Product-Related Breach is not cured within such sixty (60)-day period, provided that if Cell Medica initiates the dispute resolution proceedings under Article XI during such sixty (60)-day period, then

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the termination by Baylor shall not be effective unless and until (A) a final determination is made under Article XI that Cell Medica so committed such Product-Related Breach, and thereafter (B) Cell Medica then fails to cure such Product-Related Breach within sixty (60) days after such final determination, or

(2)upon written notice by Baylor if Cell Medica has no right to cure pursuant to Section 10.2(c)(i), provided that if Cell Medica initiates the dispute resolution proceedings under Article XI within thirty (30) days of receipt of such written notice by Baylor, then the termination by Baylor shall not be effective unless and until a final determination is made under Article XI whether the requirements of 10.2(c)(ii) have been met.

(d)Either Party may terminate this Agreement by written notice of termination to the other Party to be effective at the end of sixty (60) days after such other Party’s receipt of such notice of termination in any of the following events, which event is identified in such written notice of termination: (i) if such other Party discontinues its business operations (including such portion of its business operations to which this Agreement relates) or takes steps to dissolve or cease to exist, unless such business operations are continued in the ordinary course or such steps cease and such other Party continues to exist in good standing within such sixty (60) day period, or (ii) if such other Party admits its inability to pay its debts as they become due unless such admission is revoked or rescinded within such sixty (60) day period, or (iii) files or is or becomes subject to a petition in bankruptcy (or similar reorganization proceeding) or makes a general assignment for the benefit of its creditors, or becomes subject to the appointment of a receiver, unless such petition is dismissed, or such assignment or appointment revoked or rescinded, within such sixty (60) day period.

10.3Effects of Termination.

(a)Within thirty (30) days of the effective date of termination of this Agreement in its entirety, Baylor shall return to Cell Medica the Unallocated Amounts (if any) in Baylor’s possession existing as such effective date. For clarity, any portion of the Development Budget that is necessary for the funding of any Specific Industrial Research Agreement or Specific Industrial Clinical Research Agreement that will survive such termination pursuant to Section (b) shall be deemed to be an Allocated Amount.

(b)Upon the termination of this Agreement in its entirety, each Receiving Party shall promptly, with regard to any Confidential Information of the other Disclosing Party in the possession or control of such Receiving Party (other than that related to portions of this Agreement that do not terminate upon any such termination or that Cell Medica has the right to continue to use pursuant to the License and Option Agreement): return, or cause the return, to the Disclosing Party (or, if and to the extent expressly requested by such Disclosing Party to such Receiving Party, irretrievably destroy or dispose of as directed by such Disclosing Party) all such Confidential Information, and irretrievably delete any electronic, digital or other copy or manifestation of such Confidential Information that remains in the possession or control of such Receiving Party after such return, destruction, or disposal of such Confidential Information (except for

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backup copies created in the normal course of such Partys business, but without the right to use any such backup copies). No such termination of this Agreement shall affect any obligations of the Parties, including payment obligations, due and payable prior to such date of termination.

(c)Any Specific Industrial Research Agreement and/or Specific Industrial Clinical Research Agreement that has been executed as of the effective date of any early termination of this Agreement and has not been terminated or expired in accordance with its terms shall remain in full force and effect, and Sections 2.2, 2.5, 2.6, 2.7, 2.8(c), 2.8(e), 2.9, 2.10, 2.11, 3.1, 3.2, 3.3, 3.7, 4.1, 4.2, 4.3, 4.5, 4.6, 5.3, 5.4, 9.3, 9.4, and 9.5, and Article VI, VII, VIII and XI of this Agreement shall remain in effect with respect to such Specific Industrial Research Agreement and/or Specific Industrial Clinical Research Agreement.

10.4Survival. The following provisions shall survive any expiration of this Agreement: Sections 3.6(b) (but Section 3.6(b) will not survive expiration or termination of the License and Option Agreement), 9.3, 9.4, 9.5, 10.3, and 10.4, and Article VI, VII, VIII, XI, and VIII, and any other provisions of this Agreement that by their nature are necessary to survive the expiration or other termination of this Agreement shall survive the expiration or other termination of this Agreement.

Article XI
DISPUTE RESOLUTION

11.1Amicable Resolution. The Parties shall attempt to settle any controversy between them and arising under this Agreement amicably. To this end, a senior executive from each Party shall consult and negotiate in good faith to reach a solution. The Parties agree that the period of amicable resolution shall toll any otherwise applicable statute of limitations. If the senior executives from each Party fail to meet, or if the matter remains unresolved, for a period of thirty (30) days from the date such controversy first was raised with the other party by notice delivered under Section 12.9, either Party shall have the right to seek to settle the controversy by binding arbitration pursuant to Section 11.2.

11.2Arbitration.

(a)Subject to Sections 11.3 and 11.4, any dispute, controversy, or claim arising out of or relating to this Agreement, or the breach, termination or invalidity thereof, including claims for tortious interference or other tortious or statutory claims arising before, during or after termination, providing only that such claim touches upon matters covered by this Agreement, shall be finally settled by arbitration administered by the American Arbitration Association pursuant to the Commercial Arbitration Rules in force at the time of the commencement of the arbitration, except as modified by the specific provisions of this Agreement. It is the specific intent of the Parties that this arbitration provision is intended to be the broadest form allowed by law. This agreement to arbitrate is intended to be binding upon the signatories hereto, their principals, successors, assigns, subsidiaries and Affiliates.

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(b)The Parties agree that a final judgment on the arbitration award shall be binding, final and non-appealable other than for grounds to vacate the final award, and may be entered by any court having jurisdiction thereof.

(c)A panel of three arbitrators shall be appointed to conduct the arbitration, with each Party having the right to select one arbitrator, both of whom will agree on a third arbitrator to act as the chair of the panel. All three of such arbitrators shall be neutrals, i.e., having no affiliation with either Party.

(d)Each arbitrator must be an active or retired lawyer, having practiced actively in the field of commercial law and/or the law relevant to the subject matter of the arbitration, in each case, for at least fifteen (15) years.

(e)The law applicable to the validity of the arbitration clause, the conduct of the arbitration, including any resort to a court for provisional remedies, the enforcement of any award and any other question of arbitration law or procedure shall be the Federal Arbitration Act. The New York Convention on the Recognition and Enforcement of Foreign Arbitral Awards of June 10, 1958 shall govern any and all disputes that may be the subject of arbitration pursuant to this Agreement.

(f)The arbitrator(s) shall hear and determine any preliminary issue of law asserted by a Party to be dispositive of any claim, in whole or part, in the manner of a court hearing a motion to dismiss for failure to state a claim or for summary judgment, pursuant to such terms and procedures as the arbitrator(s) deems appropriate.

(g)The Parties and the arbitrator(s) shall treat all aspects of the arbitration proceedings, including without limitation discovery, testimony and other evidence, briefs and the award, as strictly confidential. Further, except as may be required by law, neither Party nor the arbitrator(s) may disclose the existence, content, or results of any arbitration hereunder without the prior written consent of both Parties.

(h)The seat of arbitration shall be New York, New York, USA.

(i)The arbitration shall be conducted in the English language. All submissions shall be made in English or with an English translation. Witnesses may provide testimony in a language other than English, provided that a simultaneous English translation is provided. Each Party shall bear its own translation costs.

11.3Injunctive Relief. Notwithstanding anything in this Agreement to the contrary, a Party may seek a temporary restraining order or a preliminary injunction from any court of competent jurisdiction, at any time, in order to prevent immediate and irreparable injury, loss, or damage on a provisional basis, pending the resolution of any dispute hereunder.

11.4Construction and Jurisdiction. This Agreement shall be deemed to be subject to, and have been made under, and shall be construed and interpreted in accordance with the laws of the State of New York. No conflict-of-laws rule or law that

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might refer such construction and interpretation to the laws of another state, republic, or country shall be considered.

11.5JSC Disputes. Disputes among the JSC shall not be subject to Section 11.2, and shall be resolved solely as set forth in Section 4.3(c).

Article XII
MISCELLANEOUS

12.1Use of Names.

(a)Cell Medica agrees that it shall not use in any way the name of “Baylor College of Medicine” or any logotypes or symbols associated with Baylor or any marks confusingly similar thereto or the names of any of the scientists or other researchers at Baylor without the prior written consent of Baylor.

(b)Notwithstanding Section 12.1(b), Cell Medica shall have the right: (a) as required by applicable Law, to refer to Baylor as its licensor and to this Agreement and its related agreements in a factual manner, it being expressly understood that Cell Medica shall have the right to so refer to Baylor as its licensor and to this Agreement in connection with its IPO, as required by applicable Law and/or any securities exchange on which it lists its shares in such IPO, or in connection with subsequent public filings as required under applicable Law or such securities exchanges; and (b) to make appropriate attribution to Baylor as a source of data in keeping with good scientific practice. Nothing in this Section 12.1(c) shall relieve Cell Medica of its obligations under Article VIII with respect to the material with which such use of Baylor’s name is associated.

(c)Baylor shall have the right, as required by applicable Law, to refer to Cell Medica as its licensee and to this Agreement and its related agreements in a factual manner, it being expressly understood that, Baylor shall also have the right to so refer to Cell Medica as its licensee and to this Agreement in connection with connection with its submissions regulatory, tax, and/or grant authorities. Nothing in this subsection (c) shall relieve Baylor of its obligations under Article VIII with respect to the material with which such use of Cell Medica’s name is associated.

12.2Independent Contractors. The Parties hereby acknowledge and agree that each is an independent contractor and that neither Party shall be considered to be the agent, representative, master or servant of the other Party for any purpose whatsoever, and that neither Party has any authority to enter into a contract, to assume any obligation or to give warranties or representations on behalf of the other Party. Nothing in this relationship shall be construed to create a relationship of joint venture, partnership, fiduciary or other similar relationship between the Parties.

12.3Assignment; Change of Control. Neither Party may assign or otherwise transfer this Agreement or any of its rights or obligations hereunder (either in whole or in part) to any person without the prior written consent of the other Party, or delegate any of its rights or obligations hereunder. Notwithstanding the foregoing, however, Cell Medica may delegate any of its rights or obligations hereunder and may assign or otherwise

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transfer this Agreement and its rights and obligations hereunder, either in whole or in part, without Baylors consent: (a) in connection with any Change of Control, or the transfer or sale of all or substantially all of the assets, or the business of, Cell Medica to which this Agreement relates, or (b) to any Affiliate (and, for clarity, to a New Cell Medica Group Topco); so long as Cell Medica gives Baylor prompt notice of such action and the assignee or successor entity or Affiliate, as the case may be, acknowledges its consent and agreement to the terms of this Agreement and the License and Option Agreement (and, if and as applicable all SIRAs and SICRAs in effect at such time) in writing before such assignment; and so long as such action is not entered into solely to satisfy creditors of Cell Medica. This Agreement shall be binding upon and shall inure to the benefit of the Parties and each of their respective successors, legal representatives and assignees. Any attempted assignment or other transfer of this Agreement not effected in accordance with this Article XII shall be null and void.

12.4Contract Interpretation. All references in this Agreement to Articles, Sections, Exhibits, Appendices or Schedules shall, unless otherwise expressly stated herein, mean the relevant sections, articles, exhibits, appendices or schedules to this Agreement, and the words “hereof,” “herein,” “hereby” and derivative or similar words refer to this Agreement (including any exhibits, appendices or schedules attached hereto). The captions to the several Articles and Sections hereof are not a part of this Agreement, but are merely for convenience to assist in locating and reading the several Articles and Sections hereof. Where this Agreement states that a party “shall,” “will,” or “must” perform in some manner or otherwise act or omit to act, it means that the party is legally obligated to do so in accordance with this Agreement. Unless the context otherwise clearly requires, whenever used in this Agreement: (a) the words “include”, “includes” or “including” shall be construed as incorporating also the phrase “but not limited to” or “without limitation”; (b) the word “or” includes the conjunctive and the disjunctive (i.e., “and/or”), (c) the words of any gender include the other gender, and (d) words using the singular or plural number also include the plural or singular number, respectively. Any reference to a statute is deemed also to refer to any amendments or successor legislation as in effect at the relevant time. All references to dollars, cash or “$” mean U.S. dollars. Any reference to a Contract or other document as of a given date means the Contract or other document as amended, supplemented and modified from time to time through such date. The term “sublicensee” used herein means an Affiliate Sublicensee and/or a Third Party Sublicensee unless otherwise expressly stated herein.

12.5Entire Agreement. The terms and conditions herein as well as those of the License and Option Agreement, constitute the entire agreement between the Parties and shall supersede all previous agreements, whether electronic, oral or written, between the Parties hereto with respect to the subject matter hereof and thereof. No agreement of understanding bearing on this Agreement shall be binding upon either Party hereto unless it shall be in writing and signed by the duly authorized officer or representative of each of the Parties and shall expressly refer to this Agreement. Electronic communication between the Parties shall not constitute an agreement of understanding, unless it is subsequently reduced to writing and signed by the duly authorized officer or representative of each of the Parties and shall expressly refer to this Agreement.

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12.6Non-Waiver. The Parties covenant and agree that if a Party fails or neglects for any reason to take advantage of any of the terms provided for the termination of this Agreement or if a Party, having the right to declare this Agreement terminated, shall fail to do so, any such failure or neglect by such Party shall not be a waiver or be deemed or be construed to be a waiver of any cause for the termination of this Agreement subsequently arising, or as a waiver of any of the terms, covenants or conditions of this Agreement or of the performance thereof. None of the terms, covenants and conditions of this Agreement may be waived by a Party except by its written consent.

12.7Severability. The Parties hereby agree that neither Party intends to violate any public policy, statutory or common law, rule, regulation, treaty or decision of any government agency or executive body thereof of any country or community or association of countries, and that if any word, sentence, paragraph or clause or combination thereof of this Agreement is found, by a court or executive body with judicial powers having jurisdiction over this Agreement or any of the Parties hereto, in a final, unappealable order to be in violation of any such provision in any country or community or association of countries, such words, sentences, paragraphs or clauses or combination shall be inoperative in such country or community or association of countries, and the remainder of this Agreement shall remain binding upon the Parties hereto. In lieu of such inoperative words, sentences, paragraphs or clauses, or combination of clauses, there will be added automatically as part of this Agreement, a valid, enforceable and operative provision as close to the original language as may be possible which preserves the economic benefits to the Parties.

12.8Force Majeure. No liability hereunder shall result to a Party by reason of delay in performance caused by force majeure, that is circumstances beyond the reasonable control of the Party, including, without limitation, acts of God, fire, flood, war, terrorism, civil unrest, labor unrest, or shortage of or inability to obtain material or equipment.

12.9Notices. All notices, demands or other communications to be given or delivered under or by reason of the provisions of this Agreement shall be in writing and shall be deemed to have been given: (a) when delivered personally to the recipient, to the address set forth below, if sent to the recipient by reputable express courier service (charges prepaid), or mailed to the recipient by certified or registered mail, return receipt requested.

If to Baylor:

If to Cell Medica:

 

 

Baylor College of Medicine

Kuur Therapeutics Limited

One Baylor Plaza

(f/k/a Cell Medica, Ltd.)

Cullen Building, Suite 106A

2617 Bissonnet St., Suite 300

Houston, Texas 77030

Houston, TX 77005

United States of America

United States of America

Attn: Robert F. Corrigan

Attn: Kevin S. Boyle, Sr.

 

Chief Executive Officer

 

Tel. No.: + 1-832-581-8220

 

Email: Kevin.Boyle@cellmedica.com

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If to Baylor:

If to Cell Medica:

 

 

 

 

With copy (which shall not constitute notice) to:

With copy (which shall not constitute notice) to:

 

 

Baker & McKenzie LLP

Kirkland & Ellis LLP

2001 Ross Avenue

601 Lexington Avenue

Suite 2300

New York, NY 10022

Dallas, TX 75201

United States of America

United States of America

Attn: Lisa A. Samenfeld

Attn: Guy F. Birkenmeier

Email: lisa.samenfeld@kirkland.com

 

 

12.10Counterparts. The Parties may execute this Agreement in multiple counterparts, each of which constitutes an original as against the Party that signed it, and all of which together constitute one agreement. This Agreement is effective upon delivery of one executed counterpart from each Party to the other Party. The signatures of the Parties need not appear on the same counterpart. The delivery of signed counterparts by facsimile or email transmission that includes a copy of the sending Party’s signature is as effective as signing and delivering the counterpart in person.

12.11Effect of Restatement. The Parties agree that this Restated Agreement supersedes and replaces the Original Agreement from and after the Restatement Effective Date. Notwithstanding the foregoing, the terms of the Original Agreement shall continue to apply with respect to matters that occurred prior to the Restatement Effective Date.

[Signature Page Follows]

 

 

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IN WITNESS WHEREOF, the Parties hereto have executed and delivered this Agreement in multiple originals by their duly authorized officers and representatives on the respective dates shown below, but effective as of the Effective Date.

 

 

 

 

 

 

Name:

/s/ Kevin S. Boyle, Sr.

 

Name:

/s/

 

Kevin S. Boyle, Sr.

 

 

Michael B. Dilling Ph.D., CLP

 

 

 

 

 

Title:

Chief Executive Officer

 

Title:

Director, Baylor Licensing Group

Date:

February 28, 2020

 

Date:

February 28, 2020

 

 

[Signature Page to the Amended and Restated Co-Development Agreement]


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Exhibit A-1

Form of Third Party Specific Industrial Research Agreement

The form of the Third Party Specific Industrial Research Agreement is attached hereto.

 

 

Exhibit 1


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Exhibit A-2

Form of Third Party Specific Industrial Clinical Research Agreement

The form of the Third Party Specific Industrial Research Agreement is to be provided by the Parties.

* * * * *

Exhibit 1

Exhibit 10.6

 

Certain information in this exhibit marked [*] has been excluded from the exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

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AMENDED AND RESTATED
EXCLUSIVE LICENSE AND OPTION AGREEMENT
BY AND BETWEEN
BAYLOR COLLEGE OF MEDICINE
AND

KUUR THERAPEUTICS LIMITED
(f/k/a CELL MEDICA, LTD.)

Original Effective Date: APRIL 29, 2016
Restatement Effective Date: FEBRUARY 28, 2020

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Table of Contents

Page

Article I DEFINITIONS AND CONSTRUCTION2

1.1General Definitions2

1.2Definitions Related to Technologies and Products12

1.3Definitions Related to Financial Provisions18

1.4Contract Interpretation20

Article II LICENSE GRANTS20

2.1License Grant: Licensed Core Technology & Licensed Core Products; Baylor Target Antigens20

2.2License Grant: Future Oncology Technology & Licensed Future Oncology Products20

2.3License Grant: Future Non-Oncology Technology and Future Non-Oncology Products21

2.4Qualification and Restrictions on Licenses21

2.5Government Reservation23

2.6Baylor’s Early R&D Participation Rights24

2.7Change of Control of Cell Medica27

2.8Right of First Negotiation29

Article III OPTION GRANTS29

3.1Grant of Exclusive Future Oncology Option29

3.2Grant of Exclusive Future Non-Oncology Option32

3.3Option Maintenance Terms34

3.4Option Exercise Procedure35

3.5Option Exercise Payment36

3.6Released Products and Released Technology Inventions36

3.7Technology Transfer38

3.8Expansion of Fields38

3.9Requirement for Co-Development Agreement Execution38

3.10Ownership of Optioned Rights39

Article IV OPTION FOR BAYLOR TARGET ANTIGENS; NEW ANTIGENS39

4.1Option for Baylor Target Antigens39

Article V PAYMENTS; CLOSING39

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5.1License Execution Fee39

   5.2through 5.12 [Intentionally Omitted]………………………………………………....40

5.13Royalty on Net Sales40

5.14Milestone Payments41

5.15Sublicensing Revenue Payments45

5.16Payment Addresses46

5.17Payment Conditions47

5.18Late Payments47

5.19No Precedent48

5.20No Double Payment48

Article VI REPORTING48

6.1Annual Progress Report48

6.2Notification of First Sale48

6.3Royalty Reports48

6.4Payment to Accompany Royalty Reports49

6.5Notification of Merger or Acquisition50

6.6Entity Status50

Article VII RECORDS AND INSPECTION50

7.1Accounting Records50

7.2Audit by Baylor50

7.3Payment Deficiency50

7.4Responsibility for Audit Costs51

Article VIII SUBLICENSES51

8.1Cell Medica Sublicensees51

8.2Baylor Audit Right52

8.3Service Provider Sublicensees52

8.4Enforcement52

Article IX PATENTS AND INFRINGEMENT52

9.1Patent Prosecution Responsibility52

9.2Notification of Intent Not to Pursue54

9.3Notification of Patent Prosecution Action54

9.4Cooperation54

9.5Infringement Action Procedures54

9.6Consent to Settle56

9.7Liability for Losses56

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9.8Patent Term Extension56

Article X TERM56

Article XI AGREEMENT TERMINATION56

11.1Termination by Baylor for Default56

11.2Termination by Baylor for Cell Medica Insolvency64

   11.3   [Intentionally Omitted]……………………………………………………………….58

11.4Termination by Cell Medica58

11.5Effects of Agreement Termination59

11.6Effect of Termination on Sublicensees60

11.7No Refund61

11.8Survival of Termination61

Article XII ASSIGNMENT61

Article XIII GOVERNMENTAL COMPLIANCE62

13.1Compliance with Applicable Laws62

13.2Requirement for U.S. Manufacture62

13.3Export Control Regulations62

Article XIV DISPUTE RESOLUTION62

14.1Arbitration63

14.2Injunctive Relief64

14.3Construction and Jurisdiction64

Article XV NOTICES64

15.1Addresses for Notices64

15.2Use of Reference Number64

Article XVI INDEMNITY, INSURANCE, AND WARRANTIES65

16.1Indemnity65

16.2Insurance67

16.3DISCLAIMER OF WARRANTY68

16.4EXCLUSION AND LIMITATION OF LIABILITY69

16.5Representations and Warranties69

16.6Covenants of Cell Medica69

16.7Representations and Warranties of Cell Medica70

16.8Representations and Warranties of Baylor71

16.9Baylor Private Placement Representations and Warranties72

16.10Fourth Amendment Effective Date Representations and Warranties of Baylor73

Article XVII CONFIDENTIALITY AND NON-DISCLOSURE74

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17.1Scope74

17.2Exclusion75

17.3Authorized Disclosure75

17.4Confidentiality of Agreement77

17.5Publication77

Article XVIII ADDITIONAL PROVISIONS77

18.1Use of Names78

18.2Marketing of Licensed Products78

18.3Baylor’s Disclaimers78

18.4Remedies; Injunctive Relief78

18.5Independent Contractors78

18.6Non-Waiver79

18.7Severability79

18.8Force Majeure79

18.9Entire Agreement79

18.10Counterparts80

18.11Effect of Restatement80

18.1265(n) – Bankruptcy80

 

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AMENDED AND RESTATED
EXCLUSIVE LICENSE AND OPTION AGREEMENT

This Amended and Restated Exclusive License and Option Agreement (the “Restated Agreement”), effective as of February 28, 2020 (the “Restatement Effective  Date”), is by and between Baylor College of Medicine (“Baylor”), a Texas nonprofit corporation having its principal place of business at One Baylor Plaza, Houston, Texas 77030, and Kuur Therapeutics Limited (formerly known as Cell Medica, Ltd.) (Reg. No. 05620555), a private limited company organized under the laws of England and Wales and having a principal place of business at 1 Canal Side Studios, 8-14 St Pancras Way, London, NW1 0QG, United Kingdom (“Cell Medica” or “Kuur”). As of the Restatement Effective Date, this Restated Agreement amends and restates the License and Option Agreement dated April 29, 2016, as amended by that certain First Amendment dated May 26, 2017, that certain Second Amendment dated December 5, 2017, that certain Third Amendment dated May 17, 2018, that certain Fourth Amendment dated December 19, 2018, and that certain Fifth Amendment dated September 27, 2019 (collectively, the “Original Agreement”).

WHEREAS, Baylor's mission is to advance human health through the integration of education, research, patient care and community service;

WHEREAS, Baylor owns or controls Core Subject Technology and Core Patent Rights in the Field;

WHEREAS, pursuant to the Original Agreement, Baylor has granted and Cell Medica has received from Baylor a royalty bearing, worldwide, exclusive license under the Core Subject Technology and Core Patent Rights in the Field, with certain options to extend the scope of the license under the terms set forth herein;

WHEREAS, Baylor owns or controls Future Oncology Technology and Patent Rights thereto in the Field;

WHEREAS, Future Oncology Products may be discovered, developed or otherwise arise under and/or embody Future Oncology Technology;

WHEREAS, pursuant to the Original Agreement, Baylor has granted and Cell Medica has received from Baylor an exclusive option to obtain a royalty bearing, worldwide, exclusive license under the Future Oncology Technology and Patent Rights thereto in the Field to research, develop, commercialize, and manufacture such Future Oncology Products;

WHEREAS, Baylor owns or controls Future Non-Oncology Technology and Patent Rights thereto Outside the Field;

WHEREAS, Future Non-Oncology Products may be discovered, developed or otherwise arise under and/or embody Future Non-Oncology Technology;

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WHEREAS, pursuant to the Original Agreement, Baylor has granted and Cell Medica has received from Baylor an exclusive option to obtain a royalty bearing, worldwide, exclusive license under the Future Non-Oncology Technology and Patent Rights thereto Outside the Field to research, develop, commercialize, and manufacture such Future Non-Oncology Products;

WHEREAS, in connection with the 2020 Transaction, Baylor and Cell Medica now desire to amend and restate certain terms of the Original Agreement in its entirety as set forth in this Restated Agreement.

WHEREAS, Baylor and Cell Medica have also entered, into the Co-Development Agreement dated April 29, 2016, as amended by that certain First Amendment dated July 12, 2017 and that certain Second Amendment dated February 28, 2019 (collectively, the “Original Co-Development Agreement”), for the collaborative development of Core Subject Technology, Future Oncology Technology and Future Non-Oncology Technology, and such Future Oncology Products and Future Non-Oncology Products as Cell Medica may opt to license under the terms set forth herein, such collaborative development subject to the terms set forth in the Co-Development Agreement; and

WHEREAS, in connection with the 2020 Transaction, Baylor and Cell Medica now desire to amend and restate certain terms of the Original Co-Development Agreement in its entirety as set forth in the restated Original Co-Development Agreement which was executed on an even date with the Restated Agreement (the “Restated Co-Development Agreement”).

NOW, THEREFORE, for and in consideration of the promises and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto expressly agree as follows:

Article I
DEFINITIONS AND CONSTRUCTION

1.1General Definitions. As used in this agreement the following capitalized terms (whether used in the singular or plural) not defined elsewhere in this Agreement shall have their respective meanings as set forth in this Section 1.1. Additional terms are defined in Section 1.2. Capitalized terms not otherwise defined in this Agreement shall have the meaning provided in the Co-Development Agreement.

2020 Transaction” means individually and collectively, the following transactions and agreements described in clauses (a) and (b) below (and any other transactions and agreements in connection therewith), in each case, during 2020 and consummated as of the Restatement Effective Date: (a) the entry by Cell Medica into a convertible loan agreement whereby IP2IPO Group L.P. and Schroder UK Public Private Trust PLC will advance a principal amount of up to [*] to Cell Medica (collectively, the “Series A Financing

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Transaction”); and (b) the entry by Cell Medica into an agreement with Baylor pursuant to which Baylor agrees to release the Company from all of its obligations to pay any amounts arising under, or in connection with, the Original Agreement or the Original Co-Development Agreement, including any activities in connection therewith (and as each such agreement has been amended from time to time as of the of the Restatement Effective Date) and any other amounts arising in connection with any obligations or otherwise as of or prior to the Restatement Effective Date (the “[*] Agreement”) in consideration of the allotment and issue by Cell Medica of shares to Baylor (collectively, the foregoing transactions and agreements described in clauses (a) and (b), the “Restatement Effective Date Transactions”); and all transactions and agreements arising from any contingent or other rights under, or otherwise in connection with, any Restatement Effective Date Transactions, including any person exercising its conversion rights in connection with the Series A Financing Transaction, including any such transactions consummated after the Restatement Effective Date.

Affiliate” means, with respect to a Party, any corporation, partnership, joint venture or other entity which, directly or indirectly, controls such Party, is controlled by such Party or is under common control with such Party. For the purpose of this definition of “Affiliate,” the terms “controls,” “controlled by,” and “under common control with” means (a) having the actual, present capacity to elect a majority of the directors or other governing body of an entity; or (b) having the power to direct at least fifty percent (50%) of the voting rights entitled to elect directors or other governing body.

Affiliate Sublicensee” means any Affiliate of Cell Medica to which Cell Medica grants a sublicense under any of the licenses granted to Cell Medica by Baylor under this Agreement to one or more of any of the Licensed Products pursuant to a sublicense agreement to which such Affiliate sublicensee of Cell Medica and/or Cell Medica and/or any other Affiliate of Cell Medica is a party, in accordance with Article  VIII.

Agreement” means the Original Agreement, as in effect from the Effective Date until the Restatement Effective Date, together with the Restated Agreement, which pursuant to Section 18.11 below replaces the Original Agreement in its entirety as of the Restatement Effective Date.

Annual R&D Commitment” shall have the meaning given in the Co-Development Agreement.

Antigen Option” has the meaning given in Section 4.1.

Applicable Laws” means all applicable federal, state and local laws, rules, and regulations. Applicable Laws include, without limitation, relevant provisions of the U.S. FD&C Act, GCP, GLP, GMP and Privacy Laws.

Calendar Year” means a period of one year beginning on January 1 and ending on the next December 31.

CAR” means a chimeric antigen receptor.

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[*]

Cell Medica Successor” means the surviving entity under the definition of Change of Control clause (a), the acquiring party or group under the definition of Change of Control clause (b) and/or the Third Party buyer under the definition of Change of Control clause (c).

Change of Control” means the occurrence of any of the following events: (a) any consolidation or merger of Cell Medica with or into any other entity in which the holders of Cell Medica’s outstanding voting securities immediately before such consolidation or merger do not, immediately after such consolidation or merger, retain securities representing a majority of the voting power of the surviving entity or stock representing a majority of the voting power of an entity that wholly owns, directly or indirectly, the surviving entity; (b) the sale, transfer or assignment of securities of Cell Medica representing a majority of the voting power of all of Cell Medica’s outstanding voting securities to an acquiring party or group which is not (i) an Affiliate or (ii) a New Cell Medica Group Topco; or (c) the sale of all or substantially all of Cell Medica’s assets or business to which this Agreement relates to a Third Party (i.e., not to a Cell Medica Affiliate or a New Cell Medica Group Topco). A “New Cell Medica Group  Topco” means a body corporate whose shareholders will, immediately following the relevant sale, transfer or assignment, (i) comprise substantially the same persons as the shareholders of Cell Medica and (ii) have substantially the same proportionate interests in shares in such body corporate as the shareholders of Cell Medica had in Cell Medica, in each case immediately prior to such acquisition. Notwithstanding anything to the contrary contained in this Agreement, the Parties hereby acknowledge and agree that in no event shall the 2020 Transaction constitute or otherwise be considered as a Change of Control (regardless of whether the 2020 Transaction would have otherwise constituted a Change of Control but for this sentence).

COC Closing” means the date of the closing of the first Change of Control of Cell Medica during the Term.

Co-Development Agreement” means the Original Co-Development Agreement, as in effect from the Effective Date until the Restatement Effective Date, together with the Restated Co-Development Agreement (which agreement was executed on an even date with the Restated Agreement), which pursuant to Section 12.11 of the Restated Co-Development Agreement replaces the Original Co-Development Agreement in its entirety as of the Restatement Effective Date.

Confidential Information” means and includes, individually and collectively, any proprietary or confidential Know-How or other proprietary and/or secret information (scientific, technical or commercial) of or, directly or indirectly, originating with, provided, disclosed, or made available or accessible by, or obtained from, a Party (the “Disclosing Party”), in each case, to or for the other Party (the “Receiving Party”), in connection with this Agreement or the Co-Development Agreement, whether in written, electronic, digital, visual, aural, verbal, or oral or other tangible or intangible form, whether provided,

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disclosed, made accessible or available or obtained, and whether or not labeled or otherwise identified as confidential, subject to Section 17.2.

Control” means, with respect to any material, information, or intellectual property right or any other Technology or Technology Right, that a Party (a) owns such material, information, or intellectual property right or other Technology or Technology Right, or (b) has a license or a sublicense (as applicable) to, or a right to use such material, information, or intellectual property right or other Technology or Technology Right, in each case of (a) or (b), with, as applicable, a right to access, use, or license or sublicense (as applicable), such material, Information, or intellectual property right or other Technology or Technology Right on the terms and conditions set forth herein, without violating the terms of any agreement with or obligation to any Third Party in existence as of the time such Party or its Affiliates would first be required hereunder to grant the other Party such access, right to use or license or sublicense (as applicable); except that, in each case, if (i) Baylor would “Control” any material, information, or intellectual property right or any other Technology or Technology Right but solely for a payment obligation in connection with a grant of the right to access, use, or license, or sublicense (as applicable), such material, Information, or intellectual property right or other Technology or Technology Right to Cell Medica, and (ii) Cell Medica agrees, to reimburse Baylor, or assume such payment obligation from Baylor, then such material, information, intellectual property rights or other Technology or Technology Rights shall be deemed to be Controlled by Baylor, provided that any such agreement to reimburse Baylor shall be set forth in a separate written agreement between Baylor and Cell Medica governing the terms of a license of said intellectual property right, material, or information; and/or (ii) where a license or sublicense (as applicable) shall be exclusive hereunder, if Baylor does not have the right to grant an exclusive license but has the right to grant a non-exclusive license under an agreement that is in existence as of the time Baylor would first be required hereunder to grant Cell Medica an exclusive license or sublicense (as applicable), such license or sublicense (as applicable) shall be non-exclusive until such time as Baylor has the right to grant, and grants, such exclusive license to Cell Medica. Baylor shall be under no obligation to seek the right to grant exclusive licenses, and makes no representations or warranties that it shall acquire the right to grant said license on an exclusive basis. This “Control” definition includes all other correlative meanings, including “Controlled,” “Controlling,” and “Controls”.

Data Package” shall have the meaning given in the Co-Development Agreement.

Developers” means the individuals listed under Schedule A, who were employees of Baylor at the time of Disclosure of the applicable Core Subject Technology.

Development Budget” shall have the meaning given in the Co-Development Agreement.

Development Plan” shall have the meaning given in the Co-Development Agreement.

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Disclosure” means, with respect to disclosure of a Future Oncology Invention or Future Non-Oncology Invention, a disclosure that contains sufficient detail to enable one skilled in the art to comprehend, replicate and use such invention.

Distinct Product” has the meaning given in Section 2.6(a)(ii).

Early R&D Activities” means, with respect to each Distinct Product, both (a) all pre-clinical studies required to be conducted to obtain the allowance of the initial IND with respect to such Distinct Product, and (b) the first clinical study of such Distinct Product in a human subject, whether healthy normal or patient (the “FIM Study”).

Effective Date” means April 29, 2016, the effective date of the Original Agreement.

Field” means the prevention, treatment and/or modulation of cancer in humans. For the avoidance of doubt, Field does not include the prevention, treatment and/or modulation of cancer in non-human animals.

Future Oncology Option” has the meaning set forth in Section 3.1(a). Future Non-Oncology Option” has the meaning set forth in Section 3.2(a).

IND” means any investigational new drug application, clinical trial application, clinical trial exemption or similar or equivalent application or submission for approval to conduct initial human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.

Know-How” means and includes, individually and collectively, any analyses, assays, conclusions, experiments, results, tests, candidates, prototypes, test versions, works-in-process, concepts, discoveries, technology, ideas, improvements, inventions, contracts, controls, metrics, properties, standards, data (financial, clinical, personnel, scientific, technical, or other data), designs, drawings, documents, files, records, forecasts, proposals, plans (research, commercialization, business), formulas, information, interfaces, know-how, lists (customer lists, prospect lists), materials, mechanisms, modes of action, methods, processes, procedures, protocols, techniques, specifications, systems, technologies, trade secrets in each case, whether proprietary or not, whether patentable or not, and whether in written, electronic, digital or other form (whether tangible or intangible).

Legal Costs” means all attorneys’ fees and other legal fees and expenses, filing or maintenance fees, assessments and all other costs and expenses related to prosecuting, obtaining and maintaining patent protection on the Patent Rights in the United States and foreign countries, in each case incurred in accordance with this Agreement.

Mark” means any trademark, service mark, trade name, corporate name, business name, domain name, logos, slogans, trade dress, packaging design, and other designations of source or origin of any kind, and any translation, transliteration, adaptation, derivation and combination thereof, and all intellectual or proprietary rights to or arising from any of the foregoing, including, without limitation, any common law rights,

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registration, application for registration, extension, and renewal thereof or related thereto, and all goodwill symbolized by any of the foregoing or associated therewith.

Modified NKT” means a [*].

Modified NKT Product” means any pharmaceutical product for administration to humans comprising a Modified NKT as the active agent and/or any combination pharmaceutical product for administration to humans comprising a Modified NKT as one of the active agents. A Modified NKT Product may include [*]other than Modified NKTs produced in the manufacture of such product so long as such other [*] are not represented to Baylor or any Third Party (including any Regulatory Authority) as having any therapeutic effect, and such product is developed and commercialized as a product in which the Modified NKT component is represented to be the primary active therapeutic ingredient in such product as reflected, for example, in the Development Plan and regulatory filings for such product. For clarity, a product based on a [*], will not be deemed to be a Modified NKT Product so long as such Modified NKTs are not represented to Baylor or any Third Party (including any Regulatory Authority) as having any therapeutic effect, and such product is not developed and commercialized as a Modified NKT product (i.e., a [*] Modified NKT is intended to be the primary active therapeutic ingredient in such product as reflected in the development plans and regulatory filings for such product).

Natural Killer Cell” or “NK Cell” means an innate lymphocyte that (a) displays rapid effector responses on encounter with an infected, allogeneic, or transformed cell, (b) does not express a T-cell receptor, and (c) recognizes target cells through a balance of signals from activating receptors, which recognize stress-induced ligands, and inhibitory receptors, which predominantly engage MHC class I molecules. For the avoidance of doubt, NK Cells do not include T Cells and do not include Natural Killer T Cells.

Natural Killer T Cell” or “NKT” means a cell population characterized by expression of a T cell receptor that (a) (i) recognizes glycolipid antigens presented by the CD1d molecule, and (ii) is unable to recognize any specific peptide antigens presented by major histocompatibility complex antigens, or (b)(i) in the case of NKT-like MAIT cells, recognizes metabolites of vitamin B2 or vitamin B9 presented by the MR1 molecule, and (ii) is unable to recognize any specific peptide antigens presented by major histocompatibility complex antigens. For the avoidance of doubt, “Natural Killer T Cells” and “NKTs” do not include T Cells and do not include Natural Killer Cells.

Net Sales” means, with respect to a particular Licensed Product in a particular period, the gross amount of monies or cash equivalent or other consideration that is billed, invoiced or received (whichever occurs first) for sales, leases, or other modes of transfer of Licensed Products by Cell Medica and its Affiliates or sublicensee(s) (the “Selling Party”) to independent, unrelated wholesaler(s), distributor(s) or end users (each a “Buyer” and collectively “Buyers”), during such period, less:

(a)reasonably and customary trade, quantity or cash discounts and rebates to the extent actually allowed and taken;

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(b)amounts repaid or credited to customers by reason of rejections or returns;

(c)to the extent separately stated on purchase orders, invoices or other documents of sale, taxes and/or other governmental charges (except regulatory filing fees) which are actually paid by or on behalf of the Selling Party for the production, sale, transportation, delivery or use of a Licensed Product; and

(d)reasonable charges borne by the Selling Party for handling, delivery or transportation of Licensed Products to customers through the use of Third Party delivery or transportation services, if separately stated.

The term “Net Sales” in the case of non-cash sales in a given country received by Selling Party for the sale, leases, sublicenses, or other modes of transfer of Licensed Products to end users means the greater of the average Net Sale price charged to Buyers for cash sales of such Licensed Product in such country and the fair market value based on pricing in comparable markets as determined by a Third Party appointed by mutual agreement of the Parties.

For clarity, if Cell Medica sells or transfers Licensed Products to a distributor or wholesaler, Net Sales with respect to such Licensed Products are to be calculated on that wholesaler’s or distributor’s sale to an end user NOT on Cell Medica’s sale or transfer price to that party. Licensed Products sold to any Affiliate, sublicensee or Third Party solely for use in clinical trials shall not be included in Net Sales.

New Modified NKT Product” means [*]. “Option Exercise Payment” has the meaning given in Section 3.5.

Outside the Field” means solely the prevention, treatment and/or modulation of human diseases and disorders other than cancer in humans. For the avoidance of doubt, Outside the Field does not include the prevention, treatment and/or modulation of cancer in non-human animals.

Party” means either Cell Medica or Baylor, and “Parties” means Cell Medica and Baylor.

Patent Rights” means any of the following, anywhere in the world and under any law or legal system: rights in inventions, patents, patent applications, and patent disclosures (including, without limitation, any provisional, utility, and design models and patent applications, continuation, continuation-in-part, divisional, reissue, reexamination, revision, substitution, and extension, and foreign, international, national, and other counterparts and equivalents thereof), including the rights to claim priority from any patent application therein (including the right to claim priority from the priority chain of any such patent application). With regard to a specific product or technology, such product or technology is “covered by” a Patent Right if making, using, selling, or offering to sell such product or practicing such technology, without authorization of the holder of such Patent Right would infringe at least one Valid Claim of such Patent Right.

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Pivotal Clinical Trial” means a clinical study of an investigational product in patients with the primary objective of confirming with statistical significance the efficacy and safety with the aim to obtain regulatory approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant regulatory authority in a country other than the United States.

Progressed Distinct Product” has the meaning given in Section 2.6(c).

Regulatory Authority” means any governmental or regulatory authority with jurisdiction over the research, development, manufacture, use, marketing or sale or other distribution of any Licensed Product, Licensed Technology, Future Product or Future Technology, including, without limitation, the U.S. Food & Drug Administration and any applicable foreign, state, or local equivalent. “Regulatory Authority” shall also include any non-governmental group licensed or otherwise authorized by an entity described in the preceding sentence to perform inspections, audits and/or product marketing, product study or other reviews.

Restatement Effective Date” has the meaning given in the Preamble.

ROFN Product” means solely (a) a Modified NKT Product; (b) for use in the Field and/or Outside the Field, (c) conceived, created, made, and/or developed (i) outside the Development Plan, outside the Co-Development Agreement, and outside any Specific Industrial Research Agreement or Specific Industrial Clinical Research Agreement, and (ii) without material support or contribution from the Development Budget or from any Third Party (other than where such support or contribution is received by Baylor from a governmental agency that does not limit, restrict, or qualify Baylor’s rights, title, and/or interest in resulting inventions), and (d) owned solely by Baylor and the subject of Technology Rights owned solely by Baylor.

ROFN Product Rights” means, with respect to a discrete ROFN Product, solely Technology Rights (a) covering any method, procedure, or process for manufacturing or using such ROFN Product, or feature or component of such ROFN Product; (b) conceived, created, made, and/or developed outside the Development Plan, outside the Co-Development Agreement, and outside any Specific Industrial Research Agreement or Specific Industrial Clinical Research Agreement, solely by Baylor employees in the scope of their employment, and without material support or contribution from the Development Budget or from any Third Party (other than where such support or contribution is received by Baylor from a governmental agency that does not limit, restrict, or qualify Baylor’s rights, title, and/or interest in resulting inventions), and (c) owned by Baylor.

Royalties” has the meaning set forth in Section 5.13(b).

Specific Industrial Clinical Research Agreement” or “SICRA” shall have the meaning given in the Co-Development Agreement.

Specific Industrial Research Agreement” or “SIRA” shall have the meaning given in the Co-Development Agreement.

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Sublicensing Revenue” means all (i) cash upfront payments, (ii) sublicensing fees and (iii) all sublicense maintenance fees that are paid to Cell Medica by any sublicensee in consideration for the grant of a sublicense of Cell Medica’s rights under this Agreement, but, in each case, (1) only during the Sublicensing Revenue Period, and (2) excluding the following payments:

(a)payments made in consideration for the issuance of equity or debt securities of Cell Medica or any of its Affiliates to the extent not exceeding the fair market value thereof;

(e)that portion of payments for direct or fully burdened expenses (collectively not to exceed one hundred fifty percent (150%) of direct expenses) associated with research or development as calculated in accordance with GAAP, to the extent that such expenses are separately listed and part of the sublicense;

(f)royalties or other payments based on sales of Licensed Products by the sublicensee (payment for which has been otherwise provided in Section 5.13 herein);

(g)milestone payments associated with the development and/or commercialization of Licensed Products by the sublicensee (payment for which has been otherwise provided in Section 5.14 herein); and

(h)payments for supply of Licensed Products for use in clinical trials by or on behalf of, or for resale by, any sublicensee.

Sublicensing Revenue Period” means the period commencing on the Restatement Effective Date and continuing thereafter for five (5) years immediately following the Restatement Effective Date, unless this Agreement is terminated earlier.

T Cell” means any of the lymphocytes that mature in the thymus and have the ability to recognize specific peptide antigens presented by major histocompatibility complex antigens through the receptors on their cell surface.

TCR” means a T Cell receptor.

Technology” means, collectively and individually, Know-How, apparatuses, developments, research and development information, test information, engineering, diagrams, blueprints, schematics, show-how, works, software (object code and source code), computer programs, computer applications, and documentation.

Technology Right” means any of the following, anywhere in the world and under any law or legal system: (i) rights in inventions and Patent Rights, (ii) copyrights, database rights, mask work rights, industrial design rights, registered designs, unregistered design rights, Community design rights, and any rights similar thereto, whether arising from statute, regulation, common or judicial law, treaty or otherwise, and any registration, application for registration, and renewal thereof or related thereto, any right of attribution and integrity and other moral right, (iii) right in or arising from any trade secret, Know-How, and confidential or proprietary or other information, material, items or things, and (iv) other

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intellectual or industrial property rights, priority rights, prior user rights and all other rights of a like nature; in each case whether registered or unregistered, and whether or not capable of registration, whether existing now or being recognized or created in the future, anywhere in the world and under any law or legal system, including without limitation the right to apply for the protection of the foregoing, in any part of the world, and the right to take, defend, or appeal proceedings, and recover and retain damages, and obtain all other relief and remedies in respect of infringements thereof and rights of protection of an interest therein under the laws of all jurisdictions; but “Technology Right” shall not include any Mark or any right to or arising from any Mark.

Term” means the term of this Agreement commencing on the Effective Date and ending on the earlier of the expiration under Article X or the termination of this Agreement under Article XI.

Third Party” means any person or entity who is not Cell Medica or any of its Affiliates, or Baylor or any of its Affiliates, or any employee thereof.

Third Party Sublicensee” means any Third Party sublicensee to which Cell Medica (or an Affiliate Sublicensee) grants a sublicense under any of the licenses granted to Cell Medica by Baylor under this Agreement to one or more of any of the Licensed Products pursuant to a sublicense agreement to which such Third Party sublicensee and Cell Medica and/or any Affiliate of Cell Medica is a party.

Trigger Oncology Product” has the meaning set forth in Section 3.1(a). Trigger Non-Oncology Product” has the meaning set forth in Section 3.2(b)(i).

Valid Claim” means any claim: (a) in an unexpired issued Patent Right which has not been held unenforceable, unpatentable or invalid by a decision of a court or other government agency of competent jurisdiction following exhaustion of all possible appeal processes, and which has not been admitted to be invalid or unenforceable through reissue, reexamination or disclaimer; or (b) in a pending patent application in the Patent Rights.

1.2Definitions Related to Technologies and Products. As used in this Agreement, the following capitalized terms (whether used in the singular or plural) shall have their respective meanings as set forth in this Section 1.2.

Baylor Target Antigen” means each of GD2, GPC3 and [*].

Construct” means the specific [*] included or expressed by a modified cell (e.g., by a Modified NKT). Where a modified cell includes or expresses one or more [*], “Construct” means the specific combination of such [*].

Licensed Antigen” means each Baylor Target Antigen for which Cell Medica has exercised its option pursuant to Section 4.1.

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New Antigen” has the meaning given in the Co-Development Agreement. In addition, solely for purposes of Section 5.14(a)(i), the antigen to which the New Modified NKT Product is directed shall also be deemed to be a New Antigen.

Replacement Antigen” means a New Antigen selected to replace a Baylor Target Antigen in the Development Plan in accordance with Section 4.4(d) of the Co-Development Agreement.

Baylor Target Patent Rights” means the following Patent Rights:

(a)the patents and patent applications listed under the heading “Baylor Target Patent Rights” in Schedule C,

(b)any divisions and continuations of the applications of clause (a),

(c)any continuations-in-part of the applications of clauses (a) through (b) solely to the extent the claims thereof are directed to subject matter specifically described in the patent applications of clauses (a) through (b) and are dominated by the claims of such patent applications of clauses (a) through (b),

(d)any non-U.S. applications corresponding to the applications of clauses (a) through (c) counterpart, pending or issued patents in all other countries, and

(e)any patent which issues in any jurisdiction from any of the applications of clauses (a) through (d) and any oppositions, reissues, re-examinations, or renewals of such patents.

Core Platform Patent Rights” means the following Patent Rights:

(e)the patents and patent applications listed under the heading “Core Platform Patent Rights” in Schedule C,

(f)any patent application, or any claim thereof, owned or co-owned by Baylor and filed after the Effective Date claiming Core Subject Technology or the use of Core Subject Technology, or materials developed with the use of Core Subject Technology,

(g)any divisions and continuations of the applications of clauses (a) through (b),

(h)any continuations-in-part of the applications of clauses (a) through (c) solely to the extent the claims thereof are directed to subject matter specifically described in the patent applications of clauses (a) through (c) and are dominated by the claims of such patent applications of clauses (a) through (c),

(i)any non-U.S. applications corresponding to the applications of clauses (a) through (e) counterpart, pending or issued patents in all other countries

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(j)any patent which issues in any jurisdiction from any of the applications of clauses (a) through (f) and any oppositions, reissues, reexaminations, or renewals of such patents. Schedule C shall be updated on an annual basis, or as needed via mutual agreement of the Parties.

Core Subject Technology” means and includes Licensed Core Products and Licensed Core Technology.

Licensed Core Product(s)” means:

(a)with respect to the Core Platform Patent Rights, the NKT Platform Subject Technology, or the NKT Process Subject Technology: any product that incorporates, utilizes or is made through use of the NKT Platform Subject Technology, and/or the NKT Process Subject Technology, and/or is covered by the Core Platform Patent Rights; and

(b)with respect to the NKT CAR Subject Technology, the following products, to the extent covered by the Core Target Patent Rights or incorporating, utilizing, or made through the use of, the NKT CAR Subject Technology or the Core Platform Patent Rights:

(1)any Modified NKT Product consisting of a Modified NKT expressing a CAR targeting any Licensed Antigen; and

(2)any New Modified NKT Product.

A Licensed Core Product shall be determined to be a Distinct Product in accordance with Section 2.6(a). For clarity, any Construct created pursuant to the Development Plan that meets the requirements of clause (a) or (b) of this definition of the term “Licensed Core Product(s)” will be deemed to be a Licensed Core Product (rather than a Future Product) and the Technology Rights therein and thereto shall be deemed to be part of the Licensed Core Technology Rights (rather than part of the Future Oncology Technology Rights or Future Non-Oncology Technology Rights).

Licensed Core Technology” means and includes NKT CAR Subject Technology, NKT Platform Subject Technology, and NKT Process Subject Technology.

Licensed Core Technology Rights” means and includes Technology Rights (a)  overing Licensed Core Technology (including, without limitation, the Core Platform Patent Rights), and (b) Controlled by Baylor.

NKT CAR Subject Technology” means solely Modified NKT biological materials, Technology and Know-How, in each case,

(1)useful in the Field,

(2)developed, discovered, invented, conceived of, reduced to practice or created by

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(A)any of Developers of the subject matter described in clause (a), (b) or (c) of this definition of the term “NKT CAR Subject Technology”, or

(B)any employees or contractors of Baylor working on the subject matter described in clause (a), (b) or (c) of this definition of the term “NKT CAR Subject Technology” and under the supervision of any of such Developers in Baylor’s facilities, and

(iii)Controlled by Baylor as of the Effective Date,

including, without limitation, any of the foregoing that are covered by or disclosed in the Baylor Target Patent Rights, and/or described in any of the following disclosures:

(a)BLG 11-059, “Immunotherapy of Metastatic Melanoma and Other Tumors Using Genetically Engineered GD2-Specific T Cells”; and

(b)BLG 15-055, “Glypican-3 Specific Chimeric Antigen Receptors for Adoptive Immunotherapy”;

but, in each case, excluding any biological materials, Technology, and Know-How to the extent not Controlled by Baylor.

NKT Platform Subject Technology” means solely biological materials, Technology and Know-How, in each case,

(1)useful in the Field for discovering, identifying, characterizing, and producing new Modified NKTs,

(2)developed, discovered, invented, conceived of, reduced to practice or created by

(A)any of Developers of the subject matter described in clause (a) or (b) of this definition of the term “NKT Platform Subject Technology”, or

(B)any employees or contractors of Baylor working on the subject matter described in clause (a) or (b) of this definition of the term “NKT Platform Subject Technology” and under the supervision of any of such Developers in Baylor’s facilities, and

(iii) Controlled by Baylor as of the Effective Date,

including, without limitation, any of the foregoing that are covered by or disclosed in the Core Platform Patent Rights, and/or described in any of the following disclosures:

(a)BLG 12-005, “Targeting the Tumor Microenvironment Using Manipulated NKT Cells”; and

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(b)BLG 15-093, “The identification of the NKT-cell subset that is responsible for in-vivo persistence and therapeutic activity and defining the conditions required for propagation of this subset in culture,”

but, in each case, excluding any biological materials, Technology, and Know-How to the extent not Controlled by Baylor.

NKT Process Subject Technology” means solely biological materials, Technology and Know-How, in each case,

(1)useful for producing NKTs, Modified NKTs, or Modified NKT Products in the Field,

(2)(A) developed, discovered, invented, conceived of, reduced to practice, created or used by (1) Dr. Metelitsa or (2) any employees or contractors of Baylor working in Dr. Metelitsa’s laboratory and under his direct supervision, in each case, within the scope of his or their position with Baylor, or (B) covered by the Core Platform Patent Rights, and

(3)Controlled by Baylor as of the Effective Date,

but, in each case, excluding any biological materials, Technology, and Know-How to the extent not Controlled by Baylor.

Future Products” means Future Oncology Products and Future Non-Oncology Products, as applicable.

Future Technology” means and includes Future Oncology Technology and/or Future Non-Oncology Technology, as applicable.

Future Oncology Technology” means solely biological materials, Technology and Know-How, including improvements or enhancements to the Core Subject Technology, in each case, Controlled by Baylor and:

(a)(i) developed, discovered, conceived, or created by employees or contractors of Baylor, in each case, within the scope of their position with Baylor, and (ii) arising from activities (1) under the Development Plan and (2) materially supported by payments from Cell Medica under the Development Budget; or

(b)(i) developed, discovered, invented, conceived of, reduced to practice or created for use in the Field, (ii) by (1) Dr. Metelitsa or (2) any employees or contractors of Baylor working in his laboratory and under his direct supervision, in each case, within the scope of his or their position with Baylor, and (iii) outside of the Development Plan, outside of the Development Budget, and outside the Co-Development Agreement (the “Future Metelitsa Lab Oncology Technology”); or

(c)(i) developed, discovered, invented, conceived of, reduced to practice or created by employees or contractors of a Third Party if such Third Party has

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executed a SIRA or SICRA with Baylor and/or Cell Medica that is in effect at the time of such development, discovery, invention, conception, reduction to practice or creation, and (ii) arising from activities (1) within the scope of such, as applicable, SIRA or SICRA, (2) under the Development Plan, and (3) materially supported by payments from Cell Medica under the Development Budget.

Future Oncology Patent Rights” means Patent Rights covering Future Oncology Technology Controlled by Baylor.

Future Oncology Technology Rights” means and includes Technology Rights, including any Future Oncology Patent Rights (a) related to Future Oncology Technology, and (b) Controlled by Baylor.

Licensed Future Oncology Product” has the meaning given in Section 3.1.

Future Oncology Product” means, as to a particular Future Oncology Invention, any product developed for use in the Field, including the Trigger Oncology Product, that (a) constitutes, incorporates, or utilizes, or is created or made using, such Future Oncology Invention, and/or (b) is covered by any Future Oncology Patent Rights, or is covered by other Future Oncology Technology Rights. A Future Oncology Product shall be deemed to be a Distinct Product in accordance with Section  2.6(a).

Future Oncology Invention” means either (a) a patentable invention, or (b) a separate and distinct method, biological material, product, feature or component of a product, process, technique or trade secret, in each case, within the Future Oncology Technology, and in each case, as disclosed by one or more employees or contractors of Baylor in accordance with its normal invention disclosure requirements and policies.

Future Non-Oncology Technology” means solely biological materials, Technology and Know-How, including improvements or enhancements to the Core Subject Technology, in each case:

(a)developed, discovered, invented, conceived of, reduced to practice or created for use Outside the Field;

(b)Controlled by Baylor;

(c)developed, discovered, invented, conceived of, reduced to practice or created after the Effective Date;

(d)developed, discovered, invented, conceived of, reduced to practice or created by (i) Dr. Metelitsa, (ii) any employees or contractors of Baylor working in his laboratory and under his direct supervision, in each case, within the scope of his or their position with Baylor, or (iii) employees or contractors of a Third Party within the scope of a SIRA or SICRA executed by such Third Party with Baylor or Cell Medica that is in effect at the time of such development, discovery, invention, conception, reduction to practice or creation; and

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(e)arising from activities (i) under the Development Plan and (ii) materially supported by payments made by Cell Medica under the Development Budget.

Future Non-Oncology Patent Rights” means Patent Rights (a) covering Future Non-Oncology Technology, and (b) Controlled by Baylor.

Future Non-Oncology Technology Rights” means and includes Technology Rights, including any Future Non-Oncology Patent Rights (a) covering Future Oncology Technology, and (b) Controlled by Baylor.

“Licensed Future Non-Oncology Product” has the meaning given in Section 3.2.

“Future Non-Oncology Product” means, as to a particular Future Non-Oncology Invention, any product intended for use Outside the Field, including the Trigger Non-Oncology Product, that (a) constitutes, incorporates, or utilizes, or is created or made using, such Future Non-Oncology Invention, and/or (b) is covered by any Future Non-Oncology Patent Rights or covered by other Future Non-Oncology Technology Rights. A Future Non-Oncology Product will be deemed to be a Distinct Product in accordance with Section 2.6(a).

Future Non-Oncology Invention” means either (a) a patentable invention, or (b) a separate and distinct method, biological material, product, feature or component of a product, process, technique or trade secret, in each case, within the Future Non-Oncology Technology, and in each case, as disclosed by one or more employees or contractors of Baylor in accordance with its normal invention disclosure requirements and policies.

Licensed Product” means a Licensed Core Product, a Licensed Future Oncology Product, and/or a Licensed Future Non-Oncology Product, as applicable.

Licensed Technology” means Core Subject Technology, Licensed Products, Future Oncology Inventions to which Cell Medica exercises its option pursuant to Section 3.1 and Future Non-Oncology Inventions to which Cell Medica exercises its option pursuant to Section 3.2.

1.3Definitions Related to Financial Provisions. As used in this Agreement, the following capitalized terms (whether used in the singular or plural) shall have their respective meanings as set forth in this Section 1.3.

A Preference Shares” has the meaning given to this term in the Articles of Association.

Articles of Association” means the proposed articles of association of Cell Medica in all material respects in the form attached as Appendix A.

B Preference Shares” has the meaning given to this term in the Articles of Association.

Baylor’s Account” shall mean:

[*]

 

 

 

 

 

 

 

 

 

 

 

 

BCM Preference Shares” means the BCM Preference Shares in Cell Medica with the rights set out in the Articles of Association, issued to Baylor in accordance with Article V.

Business Day” means a day (other than a Saturday or Sunday) on which banks in New York, Texas and England are open for the transaction of normal banking business.

Group Company” or “Group Companies” has the meaning given to this term in the Articles of Association.

Initial Public Offering” or “IPO” means the admission of any ordinary shares of Cell Medica or of a new holding company of Cell Medica to trading, or the granting of permission for any ordinary shares of Cell Medica or of a new holding company of Cell Medica to be dealt in, on a Recognised Investment Exchange or other internationally recognized investment exchange.

License Execution Fee” has the meaning given to this term in Section 5.1.

Liquidation Event” means a return of all or substantially all of the assets of Cell Medica on a liquidation, dissolution, winding up or similar event.

Ordinary Shares” has the meaning given to this term in the Articles of Association.

Recognised Investment Exchange” means a recognised investment exchange as defined by section 286 of the United Kingdom’s Financial Services and Markets Act 2000, as amended, together with (whether or not falling within such definition) the Main Market of the London Stock Exchange plc, the AIM market of the London Stock Exchange plc, NASDAQ, NYSE, and Euronext.

Relevant Securities” has the meaning given to this term in the Articles of Association.

Shares” has the meaning given to this term in the Articles of Association.

1.4Contract Interpretation. All references in this Agreement to Articles, Sections, Exhibits, Appendices or Schedules shall, unless otherwise expressly stated herein, mean the relevant sections, articles, exhibits, appendices or schedules to this Agreement, and the words “hereof,” “herein,” “hereby” and derivative or similar words refer to this Agreement (including any exhibits, appendices or schedules attached hereto). The captions to the several Articles and Sections hereof are not a part of this Agreement, but are merely for convenience to assist in locating and reading the several Articles and

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Sections hereof. Where this Agreement states that a party “shall,” “will,” or “must” perform in some manner or otherwise act or omit to act, it means that the party is legally obligated to do so in accordance with this Agreement. Unless the context otherwise clearly requires, whenever used in this Agreement: (a) the words “include”, “includes” or “including” shall be construed as incorporating also the phrase “but not limited to” or “without limitation”; (b) the word “or” includes the conjunctive and the disjunctive (i.e., “and/or”), (c) the words of any gender include the other gender, and (d) words using the singular or plural number also include the plural or singular number, respectively. Any reference to a statute is deemed also to refer to any amendments or successor legislation as in effect at the relevant time. All references to dollars, cash or “$” mean U.S. dollars. Any reference to a Contract or other document as of a given date means the Contract or other document as amended, supplemented and modified from time to time through such date. The term “sublicensee” used herein means an Affiliate Sublicensee and/or a Third Party Sublicensee unless otherwise expressly stated herein.

Article II
LICENSE GRANTS

2.1License Grant: Licensed Core Technology & Licensed Core Products; Baylor Target Antigens.

(a)Subject to (i) the reservations of rights set forth in Sections 2.4 and 2.5, and (ii) Baylor’s rights set forth in Section 2.6, Baylor hereby grants to Cell Medica an exclusive, worldwide, sublicensable (with the right to further sublicense through multiple tiers of sublicensees, all in accordance with Article VIII) license under the Licensed Core Technology Rights, including the Core Platform Patent Rights, to research, develop, make, have made, use, market, sell, offer to sell, lease and import Licensed Core Products in the Field (subject to expansion under Section  3.8), all under and in accordance with the terms and conditions of this Agreement and subject to the payment of Royalties and other payments applicable to such Licensed Core Products.

(b)[Intentionally Omitted.]

2.2License Grant: Future Oncology Technology & Licensed Future Oncology Products. Subject to (a) the reservations of rights set forth in Sections 2.4 and 2.5 and (b) Baylor’s rights set forth in Section 2.6, (c) completion of the Option Exercise Procedure (Section 3.4), and (d) payment of the Option Exercise Payment (Section 3.5) by Cell Medica to and receipt by Baylor, Baylor hereby grants to Cell Medica an exclusive, worldwide, sublicensable (with the right to further sublicense through multiple tiers of sublicensees, all in accordance with Article VIII) right and license under the Future Oncology Technology Rights, including the Future Oncology Patent Rights, to research, develop, make, have made, use, market, sell, offer to sell, lease and import (x) Licensed Future Oncology Products in the Field and Licensed Core Products in the Field (subject in each case to expansion under Section 3.8), and (y) any Licensed Future Non-Oncology Products both in the Field and Outside the Field (if the expansion under Section 3.8 is completed), all under and in accordance with the terms and conditions of this Agreement

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and subject to the payment of Royalties and other payments applicable to such Licensed Future Oncology Products and such Licensed Core Products.

2.3License Grant: Future Non-Oncology Technology and Future Non-Oncology Products. Subject to (a) the reservations of rights set forth in Sections 2.4  and 2.5 and (b) Baylor’s rights set forth in Section 2.6, (c) completion of the Option Exercise Procedure (Section 3.4), (d) completion of the Future Non-Oncology Product Option payment obligations (Section 3.2(c)), (e) payment of the Option Exercise Payment (Section 3.5), by Cell Medica to and receipt by Baylor, Baylor hereby grants to Cell Medica an exclusive, worldwide, sublicensable (with the right to further sublicense through multiple tiers of sublicensees, all in accordance with Article VIII) right and license under the Future Non-Oncology Technology Rights, including the Future Non-Oncology Patent Rights, to research, develop, make, have made, use, market, sell, offer to sell, lease and import (x) Licensed Future Non-Oncology Products Outside the Field (subject to expansion under Section 3.8) and (y) Licensed Core Products in the Field, and Licensed Future Oncology Products in the Field (subject in each case to expansion under Section 3.8), all under and in accordance with the terms and conditions of this Agreement and subject to the payment of Royalties and other payments applicable to such Licensed Future Non-Oncology Products and such Licensed Core Products.

2.4Qualification and Restrictions on Licenses.

(a)Ownership of Licensed Rights. Any license granted by Baylor under this Agreement under or to or regarding any Patent Right is granted by Baylor only to the extent that Baylor Controls such Patent Right. Any license granted by Baylor under this Agreement to or regarding any Technology and Technology Rights is granted by Baylor only to the extent that Baylor Controls such Technology and the Technology Rights in such Technology.

(b)License Restrictions. The grants in Sections 2.1, 2.2, and 2.3 shall be further subject to, restricted by and non-exclusive with respect to:

(1)making or using the Core Subject Technology, Future Oncology Technology, Future Non-Oncology Technology, and/or inventions claimed in the Core Platform Patent Rights, Baylor Target Patent Rights, Future Oncology Patent Rights, and Future Non-Oncology Patent Rights, as applicable, by Baylor for research, patient care, teaching and other educational activities for non-commercial purposes;

(2)any non-exclusive licenses of the Core Subject Technology, Future Oncology Technology, Future Non-Oncology Technology, and/or inventions claimed in the Core Platform Patent Rights, Baylor Target Patent Rights, Future Oncology Patent Rights, and Future Non-Oncology Patent Rights, as applicable, that Baylor may grant to other academic or non-profit research institutions for non-commercial research purposes, provided that Baylor shall notify Cell Medica in advance of any such grant made with respect to the Future Oncology Technology and Future Non-Oncology and any Core Subject Technology made after the Effective Date, but only to the extent that Baylor is

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permitted under its agreement(s) related to such grant (provided that Baylor uses reasonable efforts to obtain the right to so notify Cell Medica);

(3)making or using the Core Subject Technology, Future Oncology Technology, Future Non-Oncology Technology, and/or inventions claimed in the Core Platform Patent Rights, Baylor Target Patent Rights, Future Oncology Patent Rights, and Future Non-Oncology Patent Rights, as applicable, by academic and non-profit research institutions for non-commercial research purposes, pursuant to a non-exclusive license granted by Baylor as described above in Section 2.4(b)(ii), including Baylor’s provision of notice to Cell Medica; and

(4)any non-exclusive license of the Core Subject Technology, Future Oncology Technology, Future Non-Oncology Technology, and/or inventions claimed in the Core Platform Patent Rights, Baylor Target Patent Rights, Future Oncology Patent Rights, and Future Non-Oncology Patent Rights, as applicable, that Baylor is required by law or regulation to grant to the United States of America or to a foreign state pursuant to an existing or future treaty with the United States of America.

With respect to subclauses (i), (ii), (iii) and (iv) of this Section 2.4(b), (A) Baylor shall not conduct any clinical trial of any Progressed Distinct Product (regardless of whether or not Cell Medica has provided Baylor with written notice of Cell Medica’s intent to initiate Phase 2 clinical trials), nor grant to any Third Party the right to do so, without the written approval of Cell Medica in its sole discretion; and (B) with respect to any Progressed Distinct Product that is not subject to the immediately preceding subclause (A), Baylor and its grantees under subclause (ii), (iii) or (iv) may conduct additional Phase 1 clinical trials for such Progressed Distinct Product, provided that Baylor provides Cell Medica (1) written notice prior to the conduct of any such trial(s) so that appropriate safety data exchange reporting procedures can be established, (2) the opportunity to comment on the trial design and protocol and reasonable updates on such trial(s), and (3) the results of such trial(s), including data, promptly following their conclusion. Baylor shall promptly provide Cell Medica with any information of which it becomes aware in connection with any activity performed pursuant to this Section 2.4(b) that relates to a potential safety issue with any Licensed Product or Future Product.

(c)Present Interest in Future Technology. Nothing in this Agreement shall give or be deemed to give Cell Medica any present license, right, title, or interest in or to any Future Technology other than the options set forth in Article III (but, for clarity, without limiting the provisions of Article III, including Section 3.1(f)), and then only if and to the extent (i) Future Technology is created in accordance with this Agreement, any applicable Specific Industrial Research Agreement or Specific Industrial Clinical Research Agreement, and the Co-Development Agreement, or in Dr. Metelitsa’s lab during the Term, and (ii) Cell Medica fully complies with the requirements set forth in Article III to exercise its option(s) under Article III.

(d)Academic Freedom. Baylor shall retain, and Cell Medica acknowledges that Baylor shall retain complete academic freedom including, without limitation, all rights and freedom, in its sole discretion, (i) to direct and control its activities

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under the Development Plan (provided that nothing in this subclause (i) will release Baylor from those obligations it has expressly accepted under the Co-Development Agreement, the Development Plan or any SIRA or SICRA), (ii) to modify or terminate any activity under the Development Plan if, in Baylor’s reasonable judgment, (1) continuing the activity would jeopardize the health or safety of any patients, healthcare providers to such patients, or Baylor employees who would otherwise be involved in such activities or (2) Baylor otherwise determines that it is obligated under Applicable Laws to discontinue such activity, (iii) to direct, control, operate, begin, continue, and terminate any and all of its activities outside of the Development Plan and subject to Sections 5.2 and 5.4 of the Co-Development Agreement and Sections 2.4(b) and 3.6 of this Agreement, including its educational activities, innovative activities, research and development, (v) subject to Section 5.2 of the Co-Development Agreement, to hire, retain, dismiss, or compensate its innovators, faculty, staff, students, employees, researchers, and/or other members, and (vi) subject to only Article XVII of this Agreement, to publicly disclose, whether through publications (whether or not peer-reviewed), oral presentations, or any other means, any and all research results, data, findings, conclusions, ideas, theories, discoveries, innovations, and other information.

2.5Government Reservation. Rights under this Agreement are or may be subject to rights required to be granted to the Government of the United States of America pursuant to 35 USC Sections 200-212, 42 USC 241, 37 CFR 401, and 42 CFR 52, including a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States the subject inventions throughout the world. Rights under this Agreement are further subject to the terms of those certain Cancer Research Grant Contracts between Baylor and the Cancer Prevention and Research Institute of Texas with effective dates of April 1, 2010, December 10, 2010, and June 1, 2011 (each a “CPRIT Grant Agreement” and collectively, the “CPRIT Grant Agreements”; Exhibits A1, A2, and A3, respectively). To the extent that there is a conflict between the terms of this Agreement and the terms of the CPRIT Grant Agreements or any applicable law or regulation, (a) the terms of the law or regulation shall prevail over this Agreement and the CPRIT Grant Agreements, and (b) the CPRIT Grant Agreements shall prevail over this Agreement. Cell Medica shall use reasonable efforts to disclose sufficient information to Baylor so that Baylor can satisfy its reporting obligations to CPRIT set forth in the CPRIT Grant Agreements.

2.6Baylor’s Early R&D Participation Rights.

(a)Grant. Subject to the terms and conditions of this Agreement, Cell Medica hereby agrees that Baylor shall have the worldwide right to be Cell Medica’s exclusive academic partner to conduct all preclinical, IND-enabling Early R&D Activities with respect to each Licensed Core Product, Future Oncology Product, and Future Non-Oncology Product (“Baylor’s Exclusive Academic Partner Early R&D Participation Rights”). Without limiting Baylor’s Exclusive Academic Partner Early R&D Participation Rights set out in the foregoing sentence, Cell Medica shall have the right (either itself or through any of its Affiliates or sublicensees or any other Third Parties) to conduct Early R&D Activities, including to prepare IND applications and subsequent services and other activities as required to support clinical development with respect to each Licensed Core

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Product, Future Oncology Product and Future Non-Oncology Product which is a Distinct Product. If Cell Medica conducts Phase I clinical trial activities, Baylor will be (unless Baylor notifies Cell Medica that it does not want to be) the lead clinical center, chief (lead) investigator and will be entitled to first and last authorship academic credit with respect to such Early R&D Activities, subject to the terms and conditions of this Agreement (including Section 17.5) and the Co-Development Agreement. For the avoidance of doubt, references in this Agreement to Section 2.6(a) include the following clauses (i), (ii) and (iii) set out below in this Section 2.6(a).

(i)Cell Medica hereby grants to Baylor the worldwide, non-exclusive right to conduct Early R&D Activities with respect to each Licensed Core Product, Future Oncology Product and Future Non-Oncology Product which is a Distinct Product, such Early R&D Activities to be funded under the Development Budget.

(ii)Each Licensed Core Product and, subject to Section  2.6(a)(iii) below, each Future Oncology Product and Future Non-Oncology Product shall be a deemed a “Distinct Product” if and to the extent a Regulatory Authority (A) requires that a separate and distinct Investigational New Drug Application (IND) or Biologics License Application (BLA), or their equivalents outside the United States, be filed with respect thereto to clinically develop in humans and obtain approval to market such product or (B) if no such authorization has yet been sought, would be reasonably expected to require such separate and distinct application if or when such authorization is sought. For the avoidance of doubt, any combination product comprising a Licensed Core Product, Future Oncology Product and Future Non-Oncology Product on the one hand, and another active agent (whether or not another Licensed Core Product, Future Oncology Product or Future Non-Oncology Product) shall be deemed to be a Distinct Product separate from any such Licensed Core Product, Future Oncology Product, and Future Non-Oncology Product if the combination product is subject to a separate and distinct IND or BLA, or their non-US equivalents. For further avoidance of doubt, (x) a Licensed Core Product, Future Oncology Product, or Future Non-Oncology Product which is administered as a concurrent therapy (and not a combination product) along with another product which contains a different active agent, wherein each product is subject to a separate IND or BLA (or their non-US equivalents), shall not be considered a different Distinct Product from the Licensed Core Product, Future Oncology Product, or Future Non-Oncology Product when administered alone.

(iii)Notwithstanding anything to the contrary in this Agreement or the Co-Development Agreement, a Future Oncology Product or Future Non-Oncology Product that otherwise meets the requirements of Section 2.6(a)(ii) for a Distinct Product will only be deemed to be a Distinct Product if: (A) such product is a Modified NKT Product, or (B) such product is not a Modified NKT Product and such product contains a specific Construct or other component covered by Technology Rights owned by Baylor, is produced by a process covered by Technology Rights owned by Baylor, or is otherwise covered by Technology Rights owned by Baylor that is exclusively licensed to Cell Medica pursuant to this Agreement.

(b)[Intentionally Omitted.]

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(c)Fulfillment on a Product by Product Basis. It is understood and agreed that a Distinct Product shall be deemed a “Progressed Distinct Product” once:

(i)the Early R&D Activities have been completed by Baylor and/or Cell Medica for such Distinct Product;

(ii)the Data Package for such Distinct Product has been delivered to Cell Medica;

(iii)the Early R&D Activities have been fully funded (as between the Parties) by Cell Medica as provided in the Development Plan and Development Budget, or in the applicable SIRA or SICRA and its corresponding budget; and

(iv)if such Distinct Product is a Future Oncology Product or a Future Non-Oncology Product, Cell Medica has exercised its option with respect to such Distinct Product in accordance with Sections 3.1, 3.2, and 3.3 (as applicable) and in accordance with Section 3.4 and Section 3.5.

Cell Medica’s obligations under Section 2.6(a) shall be deemed to be completed, fulfilled, and concluded with respect to each Progressed Distinct Product and, thereafter, the rights granted under Sections 2.1, 2.2, and 2.3, solely with respect to each such Progressed Distinct Product, shall not be subject to this Section 2.6. In addition, it is understood and agreed that with respect to each Progressed Distinct Product (for so long as it remains the same Distinct Product), Cell Medica shall have all rights, without an obligation to involve Baylor, to conduct all further human clinical or nonclinical studies of such Progressed Distinct Product, in other patient populations and in other indications.

(d)In the event that Cell Medica or any of its Affiliates conducts or has conducted any preclinical, IND-enabling Early R&D Activities with respect to any Distinct Product, alone or with a Third Party independent of the Co-Development Agreement (while the Co-Development Agreement or an applicable SIRA is in effect) in contravention of Baylor’s Exclusive Academic Partner Early R&D Participation Rights set forth above in Section 2.6(a), Baylor shall have the right to terminate this Agreement solely with respect to such Distinct Product, in accordance with Section  11.1, except solely if and to the extent that:

(i)the Specific Industrial Research Agreement for such Distinct Product permits any such preclinical, IND-enabling Early R&D Activities by Cell Medica without participation of Baylor;

(ii)Cell Medica provides Baylor a written proposal for preclinical, IND-enabling Early R&D Activities for such Distinct Product, but the Parties do not reach agreement on a Specific Industrial Research Agreement for the conduct of such preclinical, IND-enabling Early R&D Activities for such Distinct Product as a result of Baylor’s demanding material terms to be included in such Specific Industrial Research Agreement, which Cell Medica shows to be objectively unreasonable;

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(iii)Baylor agrees in advance in writing to such preclinical, IND-enabling Early R&D Activities by Cell Medica without participation of Baylor;

(iv)Baylor fails to perform its obligations under the Co-Development Agreement or the Development Plan or applicable Specific Industrial Research Agreement, as set forth in the Co-Development Agreement or such Specific Industrial Research Agreement with respect to such Distinct Product or New Antigen Product;

(v)Cell Medica has terminated the Co-Development Agreement for Baylor’s material breach in accordance with Article X of the Co-Development Agreement; or

(vi)Baylor cannot perform such preclinical, IND-enabling Early R&D Activities due to its contractual obligations to a Third Party. The effects of any such termination of rights to a Distinct Product are set forth in Section 11.5.

2.7Change of Control of Cell Medica. Upon the COC Closing during the Term, the following shall apply:

(a)Early R&D Rights.

(i)Licensed Core Products. With respect to any Licensed Core Products, the conditions set forth in clause (b) of Section 2.2 and clause (b) of Section 2.3, and the license granted to Baylor under Section 2.6(a) shall continue with full force and effect as though no Change of Control had occurred.

(ii)Future Technology Products. The Cell Medica Successor may elect, upon written notice to Baylor within one hundred eighty (180) days of COC Closing, to terminate the Co-Development Agreement and, concomitantly, the conditions set forth in clause (b) of Section 2.2 and clause (b) of Section 2.3 and the license granted to Baylor under Section 2.6(a) and the rights granted to Baylor under Section 2.6(d) (the “Early R&D Rights Termination”), such termination effective only upon the later to occur of (i) the last day of the second full Calendar Year after Baylor’s receipt of such notice of termination, or (ii) the third anniversary of the Effective Date, whichever is later (the “Wind Down Period”). Upon expiration of the Wind Down Period, the conditions set forth in clause (b) of Section 2.2 and clause (b) of Section  2.3 and the license granted to Baylor under Section 2.6(a) and the rights granted to Baylor under Section 2.6(d) shall be deemed terminated with respect to any and all Licensed Future Oncology Products and Licensed Future Non-Oncology Products licensed to Cell Medica as of the last day of the Wind Down Period or thereafter, including all Future Oncology Products or Future Non-Oncology Products as to which Cell Medica exercises its options under Section 3.1 and Section 3.2, respectively, during the Wind Down Period or pursuant to Section 2.7(c) below.

(iii)For the avoidance of doubt, effective upon any Early R&D Rights Termination, with respect to one or more Future Technology Products which include, incorporate, or utilize or are made with, any Future Oncology Invention or Future Non-Oncology Invention that is not licensed to Cell Medica or the Cell Medica Successor

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as of the last day of the Wind Down Period, or thereafter, pursuant to, but only to the extent of, any then-ongoing options under any then-existing SIRA or SICRA that continues past the last day of the Wind Down Period (each, an “Independent Product”), Baylor has and shall retain the right to conduct, at its own expense, Early R&D Activities related to such Independent Products, provided that the Cell Medica Successor shall have a right of first negotiation solely during such Wind Down Period with respect to any such Independent Product in the event Baylor seeks to license rights to such Independent Product.

(b)Obligations during the Wind Down Period. During the Wind Down Period, the Cell Medica Successor shall:

(i)Cause its designated members to participate fully and in good faith in the JSC including appointing its allotted JSC members in accordance with Section 4.2 of the Co-Development Agreement promptly after the COC Closing, and participating in drafting, adopting, and revising the Development Plan and the Development Budget. Baylor shall also cause its designated JSC members to participate fully and in good faith in the JSC, including participating in drafting, adopting, and revising the Development Plan and the Development Budget during the Wind Down Period;

pay (A) any unpaid portion of the Allocated Amounts (as defined in the Co-Development Agreement) for the remainder of the year in which the COC Closing occurs and (B) the Allocated Amounts for each of the two full Fiscal Years (as defined in the Co-Development Agreement) of the Wind Down Period, which amount, in aggregate for such two full Fiscal Years of the Wind Down Period, shall be, subject to clause (iv) of this Section 2.7(b), either:

[*], inclusive of the amounts paid for any funding of preclinical and FIM Studies required to be funded as noted in clauses (iii) and (iv) of this Section 2.7(b) (the “Ceiling Amount”)]; or

 

(y)

the Budgeted Amount (as defined below), if the Ceiling Amount is greater than the amount equal to [*] of sum of the Allocated Amounts for each of such remaining two full Fiscal Years of the Wind Down Period, to the extent agreed upon in the Development Plan existing as of the date of such termination notice (the “Budgeted Amount”); by way of example:, if the Allocated Amounts for the first of the two Fiscal Years was $[*] and for the second of the two Fiscal Years was $[*], the amount owed would be $[*] (i.e., [*] of the aggregate Budgeted Amount of $[*])[*];

fund any preclinical studies under any Specific Industrial Research Agreements or Specific Industrial Clinical Research Agreement or other documented plan and in

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progress at the time of the Change of Control, through the end of the Wind Down Period; and

fund to completion and complete (subject to any technical failure of the relevant product) any FIM Studies in progress at the time of the Change of Control, even if such FIM Studies extend beyond the Wind Down Period (such period extending beyond the Wind Down Period, the “Tail Period”).

(c)Retention of Option Rights During Wind Down. The Cell Medica  Successor shall have the options provided under Sections 3.1 and 3.2 (i) during the Wind Down Period with respect to any Future Oncology Products and Future Oncology Inventions or Future Non-Oncology Products and Future Non-Oncology Inventions arising under the Development Plan and funded by the Development Budget, and (ii) during the Tail Period with respect to any Future Oncology Products and Future Oncology Inventions or Future Non-Oncology Products and Future Non-Oncology Inventions arising during the Tail Period under specific SIRAs or SICRAs as provided in Section 2.7(b)(iv).

(d)Other Termination of the Co-Development Agreement during Wind Down. During the Wind Down Period, each Party shall retain its rights under Article X of the Co-Development Agreement.

2.8Right of First Negotiation. Subject to the last sentence of this Section 2.8, Cell Medica shall have a right of first negotiation with respect to any ROFN Product and associated ROFN Product Rights as and to the extent provided under this Section 2.8. Following the disclosure to Baylor of any ROFN Product and associated ROFN Product Rights (whether or not patentable) by Baylor employees, and prior to offering a license to any Third Party with respect thereto, Baylor shall inform Cell Medica of such disclosure and provide a written summary of such ROFN Products and associated ROFN Product Rights. Cell Medica shall have a period of [*]days to elect to exercise such right of first negotiation, and upon written notice thereof in such time period, Baylor shall negotiate with Cell Medica, in good faith, for a period of [*] days, the commercially reasonable terms of a license agreement for such ROFN Product that is the subject of such invention disclosure and the associated ROFN Product Rights. In the event the Parties are unable to agree on such license agreement in such time period, Baylor shall not have the right to license such ROFN Product or such associated ROFN Product Rights to a Third Party on terms that are less favorable to Baylor than the terms last offered by Cell Medica for a period of [*] days. The right of first negotiation under this Section 2.8 shall terminate upon termination or expiration of the later of: (i) the Co-Development Agreement or (ii) the Tail Period. Notwithstanding the foregoing, with respect to any ROFN Product which is directed to the same target as to which any Licensed Core Product is directed, Baylor’s sole obligation with respect thereto shall be to so inform Cell Medica of such ROFN Product and provide to Cell Medica a written summary of such ROFN Product and its associated ROFN Product Rights.

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Article III
OPTION GRANTS

3.1Grant of Exclusive Future Oncology Option.

(a)Effective upon payment of the License Execution Fee in Section 5.1, and subject to Section 3.3, Baylor hereby grants to Cell Medica an exclusive option (the “Future Oncology Option”) to obtain the license set forth in Section 2.2 with respect to each Future Oncology Invention, as all further described in this Section 3.1. The option period for a given Future Oncology Invention shall commence upon Disclosure of such Future Oncology Invention to the JSC under the Co-Development Agreement (or in the case of any Future Oncology Invention which constitutes Future Metelitsa Lab Oncology Technology, following the Disclosure to Baylor of such Future Oncology Invention, Baylor shall so provide Cell Medica such Disclosure in writing, and the option period with respect thereto shall commence as of the date of such Disclosure), in each case, a “Future Oncology Invention  Disclosure Date,” and shall expire [*]after the delivery to Cell Medica of the Data Package for the FIM Study with respect to the first Future Oncology Product which embodies, includes or incorporates, or is made using, such Future Oncology Invention (the “Trigger Oncology Product”), subject to Section 3.1(b). If Cell Medica exercises such option prior to the conduct of the FIM Study for such Trigger Oncology Product, Baylor shall retain the right to continue to conduct the FIM Study for such Trigger Oncology Product under and in accordance with the terms of the Co-Development Agreement and Section 2.6.

(b)Notwithstanding Section 3.1(a), the option period for a Future Oncology Invention shall expire (i) [*] after the Future Oncology Invention Disclosure Date if such Future Oncology Invention has not been incorporated into the Development Plan within such [*] period (provided that (A) the option period shall not so expire if such Future Oncology Invention is not incorporated into the Development Plan due to Baylor’s JSC members not agreeing to incorporate such Future Oncology Invention into the Development Plan or Baylor’s lack of resources or capacity to perform Early R&D Activities for such Future Oncology Invention, or (B) if any part of the FIM Study is conducted by Baylor, then such option shall not expire until [*] after the delivery to Cell Medica of the Data Package for such FIM Study with respect to such Future Oncology Invention; or (ii) if such Future Oncology Invention is dropped from the Development Plan, twelve (12) months after such Future Oncology Invention is dropped from the Development Plan, provided that such Future Oncology Invention is not dropped from the Development Plan due to Baylor’s lack of resources or capacity to perform Early R&D Activities for such Future Oncology Invention[*].

(c)When exercising its option with respect to a particular Future Oncology Invention (and its associated Future Oncology Patent Rights), Cell Medica shall have the right to exercise such option:

(i)solely with respect to, and as embodied in, or used to manufacture or create, the relevant Trigger Oncology Product, and not as to all other

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Future Oncology Products (an “Oncology Product-Only Exercise”), in which event the license granted in Section 2.2 with respect to such Future Oncology Invention shall be restricted to only such Trigger Oncology Product, and only one Option Exercise Payment shall be due to Baylor;

(ii)solely with respect to such Future Oncology Invention (and its associated Future Oncology Patent Rights), but not the specific Trigger Oncology Product (an “Oncology Invention-Only Exercise”), in which event the license granted in Section 2.2 with respect to such Future Oncology Invention shall include all Future Oncology Products other than the Trigger Oncology Product, and only one Option Exercise Payment shall be due to Baylor with respect to such Future Oncology Invention (or more than one such payment, if the option is being exercised to more than one Future Oncology Invention embodied in, or used to manufacture or create the Trigger Oncology Product at such time); or

(iii)both (A) with respect to the particular Trigger Oncology Product, as well as (B) with respect to one or more Future Oncology Inventions embodied in, or used to manufacture or create, such Trigger Oncology Product (an “Oncology Product and Invention Exercise”), in which event the license granted in Section 2.2 with respect to such Future Oncology Invention shall include both the Trigger Oncology Product and all other Future Oncology Products, and an Option Exercise Payment shall be due to Baylor for the exercise with respect to the Trigger Oncology Product as well as to each of the Future Oncology Inventions. (For the purpose of exemplary illustration of such Option Exercise Payment only, and without implying any cap on the Option Exercise Payment: [*] in total would be owed upon an Oncology Product and Invention Exercise for only one Future Oncology Invention or a total of [*] in total would be owed upon an Oncology Product and Invention Exercise for two separate Future Oncology Inventions.)

(d)It is expressly understood that a particular Trigger Oncology Product as to which Baylor conducts a FIM Study may include, incorporate, or embody, or have been made using, more than one Future Oncology Invention, one or more of which Cell Medica has not yet exercised its option with respect to as of the time of delivery to Cell Medica of the Data Package. In such event, Cell Medica may exercise some or all of such options to the separate Future Oncology Inventions, all as provided in Section 3.1(c) and in accordance with Section 3.5, and each exercise would be subject to a separate Option Exercise Payment. It is also understood that a particular Trigger Oncology Product as to which Baylor conducts a FIM Study may include, incorporate, or embody, or have been made using either (i) one or more Future Oncology Inventions as to which Cell Medica has already exercised its option, as of the time of delivery to Cell Medica of the Data Package therefor, or (ii) one or more inventions or aspects of the Core Subject Technology, in each of which event, Cell Medica would be required to make a separate Option Exercise Payment only for the Future Oncology Invention as to which it had not yet exercised its option, and not with respect to those Future Oncology Inventions as to which it had previously exercised its option or to any Core Subject Technology already licensed to Cell Medica under Section 2.1.

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(e)For clarity, the exclusive license granted by Baylor to Cell Medica under Section 2.2 upon an Oncology Invention-Only Exercise or an Oncology Product and Invention Exercise with respect to a particular Future Oncology Invention pursuant to Sections 3.1(c)(ii) or (iii), respectively, and in accordance with Sections 3.4 and 3.5, shall not include a license to research, develop, make, have made, use, market, sell, offer to sell, lease and import Licensed Core Products and Future Oncology Products in the Field that incorporate or utilize any Future Oncology Invention as to which Cell Medica has not yet exercised its license option.

(f)Notwithstanding anything contained herein to the contrary in this Agreement or the Co-Development Agreement, the Parties hereby acknowledge and agree that: (i) as of or prior to the Restatement Effective Date, Cell Medica has exercised, or has been deemed to have exercised, any option hereunder that applies to the New Modified NKT Product, and (ii) no option or other payments are required or owed by Cell Medica in connection with any such exercised, or deemed exercised, option hereunder that applies to the New Modified NKT Product.

3.2Grant of Exclusive Future Non-Oncology Option.

(a)Option Grant. Effective upon Cell Medica fulfilling the payment obligations set forth in clauses (i) and (ii) of Section 3.2(c), and subject to the conditions and restrictions below and Section 3.3, Baylor hereby grants to Cell Medica an exclusive option (the “Future Non-Oncology Option”) to obtain the license set forth in Section 2.3 with respect to each Future Non-Oncology Invention.

(b)Option Period.

(i)The option period for a given Future Non-Oncology Invention shall be in effect only following receipt of payment of the Future Non-Oncology Technology Research & Development Payment under Section 3.2(c)(ii), and shall commence upon Disclosure of such Future Non-Oncology Invention to the JSC under the Co-Development Agreement, and expire [*] months after the delivery to Cell Medica of the Data Package for the FIM Study with respect to the first Future Non-Oncology Product which embodies, includes or incorporates, or is made using, such Future Oncology Invention (the “Trigger Non-Oncology Product”), subject to Section 3.2(b)(ii). If Cell Medica exercises such option prior to the conduct of the FIM Study for such Trigger Non-Oncology Product, Baylor shall retain the right to continue to conduct the FIM Study for such Trigger Non-Oncology Product under and in accordance with the terms of, the Co-Development Agreement and Section 2.6.

(ii)Notwithstanding Section 3.2(b)(i), the option period for a Future Non-Oncology Invention shall expire (A) [*] after the Future Non-Oncology Invention Disclosure Date if such Future Non-Oncology Invention has not been incorporated into the Development Plan within such [*] period (provided that (1) the option period shall not so expire if such Future Non-Oncology Invention is not incorporated into the Development Plan due to Baylor’s JSC members not agreeing to incorporate such Future Non-Oncology Invention into the Development Plan or Baylor’s lack of resources

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or capacity to perform Early R&D Activities for such Future Non-Oncology Invention), or (2) if any part of the FIM Study is conducted by Baylor, then such option shall not expire until [*] after the delivery to Cell Medica of the Data Package for such FIM Study with respect to such Future Non-Oncology Invention; or (B) if such Future Non-Oncology Invention is dropped from the Development Plan, [*] after such Future Non-Oncology Invention is dropped from the Development Plan, provided that such Future Non-Oncology Invention is not dropped from the Development Plan due to Baylor’s lack of resources or capacity to perform Early R&D Activities for such Future Non-Oncology Invention.

(iii)When exercising its option with respect to a particular Future Non-Oncology Invention (and its associated Future Non-Oncology Patent Rights), Cell Medica shall have the right to exercise such option:

(3)solely with respect to, and as embodied in, or used to manufacture or create, the relevant Trigger Non-Oncology Product, and not as to all other Future Non-Oncology Products (a “Non-Oncology Product-Only Exercise”), in which event the license granted in Section 2.3 with respect to such Future Oncology Invention shall be restricted to only such Trigger Non-Oncology Product, and only one Option Exercise Payment shall be due to Baylor;

(4)solely with respect to such Future Non-Oncology Invention (and its associated Future Non-Oncology Patent Rights), but not the specific Trigger Non-Oncology Product (a “Non-Oncology Invention-Only Exercise”), in which event the license granted in Section 2.3 with respect to such Future Non-Oncology Invention shall include all Future Non-Oncology Products other than the Trigger Oncology Product, and only one Option Exercise Payment shall be due to Baylor with respect to such Future Non-Oncology Invention (or more than one such payment, if the option is being exercised to more than one Future Oncology Invention embodied in, or used to manufacture or create the Trigger Oncology Product at such time); or

(5)both (x) with respect to the particular Trigger Non-Oncology Product, as well as (y) with respect to one or more Future Non-Oncology Inventions embodied in, or used to manufacture or create, such Trigger Non-Oncology Product (a “Non-Oncology Product and Invention Exercise”), in which event the license granted in Section 2.3 with respect to such Future Non-Oncology Invention shall include both the Trigger Non-Oncology Product and all other Future Non-Oncology Products, and an Option Exercise Payment shall be due to Baylor for the exercise with respect to the Trigger Oncology Product as well as to each of the Future Oncology Inventions with respect to which it exercised such option (e.g., [*] in total would be owed upon a Non-Oncology Product and Invention Exercise for only one Future Non-Oncology Invention or a total of [*] would be owed upon a Non-Oncology Product and Invention Exercise for two separate Future Non-Oncology Inventions).

(iv)It is expressly understood that a particular Trigger Non-Oncology Product as to which Baylor conducts a FIM Study may include, incorporate, or embody, or have been made using, more than one Future Non-Oncology Inventions, one or more of which Cell Medica may have not yet exercised its option with respect to as of the

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time of delivery to Cell Medica of the Data Package. In such event, Cell Medica may exercise some or all of such options to each of the separate Future Non-Oncology Inventions, all as provided in Section 3.2(b)(iii) and in accordance with Sections 3.4 and 3.5 and during the Option Period for such Trigger Non-Oncology Product, and each exercise would be subject to a separate Option Exercise Payment. It is also understood that a particular Trigger Non-Oncology Product as to which Baylor conducts a FIM Study may include, incorporate, or embody, or have been made using either (A) one or more Future Non-Oncology Inventions as to which Cell Medica has already exercised its option, as of the time of delivery to Cell Medica of the Data Package therefor, or (B) one or more inventions or aspects of the Core Subject Technology, in each of which event, Cell Medica would be required to make a separate Option Exercise Payment only for the Future Oncology Invention as to which it had not yet exercised its option, and not with respect to those Future Oncology Inventions as to which it had previously exercised its option, or to any Core Subject Technology already licensed to Cell Medica under Section 2.1.

(c)Conditions. The grant of the Future Non-Oncology Option in Section 3.2(a) is conditioned on, subject to, and restricted by the following terms:

(i)Future Non-Oncology Product Option Payment. Cell Medica shall pay, and does pay, Baylor a one-time, non-refundable, payment of [*] on or before the earlier of (A) the date on which Cell Medica first exercises its option under Section 3.2 or (B) December 31, 2020 (the “Future Non-Oncology Product Option Payment”). If Cell Medica fails to make said Future Non-Oncology Product Option Payment, Baylor shall be free to commercialize the Future Non-Oncology Technology with Third Parties without any further obligation to Cell Medica or any limitation under this Agreement, other than as set forth in Article XVII.

(ii)Future Non-Oncology Technology Research & Development Payment. In addition to the Future Non-Oncology Product Option Payment, Cell Medica shall also pay, and does pay, [*] in addition to and at the same time as the [*] Quarterly R&D Payment (as defined under and in accordance with conditions set forth in the Co-Development Agreement) to support the research and development of Future Non-Oncology Technology as set forth in the proposed Development Plan and Budget therefor (the “Future Non-Oncology Technology Research & Development Payment”). Notwithstanding the foregoing, Cell Medica shall not be obligated to make the Future Non-Oncology Technology Research & Development Payment until Baylor has provided Cell Medica with an acceptable work plan for use of such funds, and Cell Medica has agreed that such work plan is acceptable.

3.3Option Maintenance Terms. The Future Oncology Option (Section 3.1) and the Future Non-Oncology Option (Section 3.2) will continue in force until the termination of the Co-Development Agreement (such period, the “Option Maintenance Period”), subject to Section 2.7. Upon termination under this Section 3.3 of the Future Oncology Option and/or the Future Non-Oncology Option (other than as provided in Section 2.7), all rights in Future Oncology Inventions and the Future Non-Oncology Inventions as to which Cell Medica has not, as of such time, exercised its option will remain with Baylor, and all contingent future interests shall automatically, without need for any notice or other

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action, terminate, and Cell Medica shall not have any right to any license under this Agreement for such Future Technology; provided, however that the following shall apply in such event:

(a)if such termination occurs within the six-month period after delivery of the Data Package referred to in Section 3.1, or Section 3.2(b) for any particular Future Oncology Product and/or Future Non-Oncology Product, the option to the Future Oncology Invention(s) relevant to such particular Future Oncology Option or Future Non-Oncology Invention(s) relevant to such Future Non-Oncology Option shall survive to the end of the Option Period under Section 3.1 or Section  3.2(b), and solely with respect to such invention(s); and

(b)such termination of the Co-Development Agreement shall not affect any then-ongoing Specific Industrial Research Agreements or Specific Industrial Clinical Research Agreement, which shall continue in accordance with its terms, all as further provided in the Co-Development Agreement, and Cell Medica shall retain the option rights set forth in Section 3.1 or Section 3.2, as applicable, with respect to any Future Technology and/or Future Oncology Products or Future Non-Oncology Products arising from such continuing Specific Industrial Research Agreement(s) or Specific Industrial Clinical Research Agreement(s).

(c)For the avoidance of doubt, ROFN Products are not subject to the options under Section 3.1 and Section 3.2.

3.4Option Exercise Procedure.

(a)Future Oncology Products. For each distinct Future Oncology Invention, and for each Trigger Oncology Product in which any such invention is embodied, included or incorporated, or used to make, if Cell Medica elects to exercise its option set forth in Section 3.1 it shall deliver to Baylor during the Option Period written notice of such election to exercise its option under Section 3.1  identifying each such distinct Future Oncology Invention and/or Trigger Oncology Product elected, accompanied by payment of the appropriate Option Exercise Payment. With respect to a distinct Future Oncology Invention or Oncology Trigger Product, the Future Oncology Option under Section 3.1 shall be deemed exercised solely upon receipt by Baylor of such Option Exercise Payment by Cell Medica.

(b)Future Non-Oncology Products. For each distinct Future Non-Oncology Invention, and for each Trigger Non-Oncology Product in which any such invention is embodied, included or incorporated, or used to make, if Cell Medica elects to exercise its option set forth in Section 3.2 it shall deliver to Baylor during the Option Period written notice of such election to exercise its option under Section  3.2 identifying each to such distinct Future Non-Oncology Invention and/or Trigger Non-Oncology Product elected, accompanied by payment of the appropriate Option Exercise Payment. With respect to a distinct Future Non-Oncology Invention or Non-Oncology Trigger Product, the Future Non-Oncology Option under Section 3.2 shall be deemed exercised solely

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upon (i) receipt by Baylor of such Option Exercise Payment by Cell Medica and (ii) satisfaction of the other conditions set forth in Section 3.2(c).

3.5Option Exercise Payment. A payment of [*] (“Option Exercise Payment”) shall be paid by Cell Medica to Baylor for the exercise of the Future Oncology Option as to each Future Oncology Invention or Trigger Oncology Product, as the case may be, or for the exercise of the Future Non-Oncology Option with respect to each Future Non-Oncology Invention or Trigger Non-Oncology Product, as the case may be, in each case for which Cell Medica exercises the applicable option, in accordance with Sections 3.1, 3.2 and 3.4.

3.6Released Products and Released Technology Inventions.

(a)Release of Option. If Cell Medica does not exercise its option with regard to a distinct Future Oncology Invention or Trigger Oncology Product during the option period under Section 3.1 or with regard to a distinct Future Non-Oncology Invention or Trigger Non-Oncology Product during the option period under Section 3.2(b), (each, a “Released Invention” or “Released Product” as the case may be), Baylor shall thereafter have the right to assign, sell, license, or otherwise transfer any rights including any Technology Rights owned by Baylor covering such Released Invention or such Released Product (but no other invention already licensed to Cell Medica and subject to any existing license rights of Cell Medica in and to any such Released Invention as it may relate to a Trigger Oncology Product or Trigger Non-Oncology Product, as the case may be, for which it has exercised its option), to any Third Party without the written consent of Cell Medica, if:

(i)Cell Medica (collectively with Cell Medica and its Affiliates and sublicensees) has fewer than three (3) Licensed Core Products and/or Future Oncology Products or Future Non-Oncology Products in development or commercialization; except where the JSC terminated the Early R&D Activities for a Licensed Core Product or a Future Oncology Product or a Future Non-Oncology Product less than 90 days prior to the expiration of the Option Period and has not yet determined a replacement product therefor;

(ii)Such Released Invention is not subject to further use under the Development Plan in connection with other Future Products, as the Development Plan exists as of the time such invention becomes a Released Invention (provided this Section 3.6(a)(ii) shall not prevent Baylor from granting a license to a Released Product, so long as the license granted for such Released Invention extends solely to the use of such Released Invention for the use, manufacture and sale of such Released Product); and

(iii)the license agreement with such Third Party with respect to any such Released Invention and/or Released Product requires that such Third Party pay to Baylor economic terms equivalent to or better than the lesser of (i) the upfront, milestones and royalties set forth in this Agreement with respect thereto, as of such time, or (ii) those last offered by Cell Medica within the preceding 180 days with respect to such Released Invention and Released Product.

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Notwithstanding the foregoing, at no time shall Baylor have the right (even if the conditions in clauses (i), (ii) and (iii) of this Section 3.6(a) are met) to so license its rights to a Released Product or to a Released Invention to a Third Party if such Released Product or any product incorporating or utilizing, or made using such Released Invention has the same molecular target as (A) any Licensed Product, or (B) any Future Product being developed under the Development Plan or a SIRA or SICRA that has not become a Released Product.

(b)Sharing of Proceeds. If Baylor licenses rights to a Released Product as and to the extent permitted under this Section 3.6, Cell Medica and Baylor shall share the amounts received by Baylor under such license: (i) [*] until the amounts received by Cell Medica under this Section 3.6 equal Cell Medica’s payments under the Development Plan and disbursed in accordance with the Development Budget for such Released Product, and (ii) thereafter, with [*].

(c)Third Party Components. In the event that a Released Product incorporates Technology that has been licensed to Cell Medica from a Third Party for use by both Cell Medica and Baylor, Cell Medica shall use reasonable good-faith efforts to arrange for a product-specific sublicense to Baylor which can be further sublicensed to a Third Party, where Baylor is permitted to grant such a license to a Third Party under Section 3.6(a). In such cases, however, Cell Medica will not be required to sublicense any such technologies if such an arrangement results in Cell Medica being required to pay any amount to its Third Party licensor, or is not justified by reasonable business terms and conditions and in particular if the cash flow implications of extending such a sublicense to Baylor and/or to such Third Party would negatively impact Cell Medica.

(d)Exclusivity. From the Effective Date until such time as Baylor is permitted to grant a license to any Released Product or Released Invention under Section 3.6(a), Baylor shall not offer to any Third Party any rights, or options to obtain rights, to the Future Oncology Technology or the Future Non-Oncology Technology or any product associated therewith, except as and solely to the extent required under the Existing Third Party Agreement as in effect on the Effective Date.

3.7Technology Transfer. Upon completion of the FIM Study and exercise by Cell Medica of its option under Sections 3.1 or 3.2, Baylor shall transfer to Cell Medica all Technology in Baylor’s possession or control, to the extent not already in Cell Medica’s possession, relating to the Future Oncology Invention or Future Non-Oncology Invention (each, an “Invention”) and/or Trigger Oncology Product or Trigger Non-Oncology Product, as the case may be (each, a “Trigger Product”) for which such option was exercised, including all Technology relating to the Trigger Product (if the option is so exercised) and any Future Product which embodies, includes or incorporates, or is made using, such Invention (if the option to such Invention is exercised). In addition, Baylor will provide (a) reasonable assistance and cooperation in order to enable Cell Medica or its designee to implement and utilize such transferred Technology, (b) provide Cell Medica with access to Baylor’s employees and contractors with appropriate expertise to answer Cell Medica’s questions related to such transfer; and (c) to Cell Medica or its designee its inventory of such Future Product and in-process materials (if any) if applicable.

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3.8Expansion of Fields.

(a)Expansion Outside the Field. Cell Medica is hereby granted the exclusive option to expand the field of use of the license granted to any and all Licensed Core Products, subject to any and all conditions set forth in Section 2.1, and Licensed Future Oncology Products, subject to any and all conditions set forth in Section 2.2, to any indication or applications Outside the Field. Such option shall be exercisable at any time after the payment to Baylor of the Future Non-Oncology Product Option Payment under Section 3.2(c), by written notice to Baylor thereof. Following such exercise, (i) the license grant in Sections 2.1 and 2.2 to Licensed Core Products shall be automatically deemed to be both for uses in the Field and Outside the Field; and (ii) the license grant in Section 2.2 to Licensed Future Oncology Products shall be automatically deemed to be both for uses in the Field and Outside the Field.

(b)Expansion to the Field. Cell Medica is hereby granted, subject to any and all conditions set forth in Section 2.3, the exclusive option to expand the field of use of the license granted to any and all Licensed Future Non-Oncology Products to any indication or applications in the Field. Such option shall be exercisable at any time after the payment to Baylor of the Future Non-Oncology Product Option Payment under Section 3.2(c), by written notice to Baylor thereof. Following such exercise, the license grant in Section 2.3 to Licensed Future Non-Oncology Products shall be automatically deemed to include both uses in the Field and Outside the Field, and the license grant in Section 2.2 under Future Oncology Technology shall include the right to research, develop, make, have made, use, market, sell, offer to sell, lease and import Licensed Future Non-Oncology Products.

3.9Requirement for Co-Development Agreement Execution. The licenses to the Core Subject Technology under Section 2.1 and the Future Oncology Option under Section 3.1 are being granted by Baylor to Cell Medica with the requirement for the contemporaneous execution of the Co-Development Agreement, subject to the terms and conditions of the Co-Development Agreement. For the avoidance of doubt, Cell Medica will not be entitled to exercise its Future Technology Option unless it also executes the Co-Development Agreement.

3.10Ownership of Optioned Rights. Any option granted by Baylor under this Agreement to receive any license under or to or regarding any Patent Right or other Technology Right is granted by Baylor only to the extent that Baylor Controls such Patent Right or other Technology Right. Any option granted by Baylor under this Agreement to receive any license under or to or regarding any Technology or Technology Right is granted by Baylor only to the extent that Baylor Controls such Technology and the Technology Rights in such Technology.

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Article IV


OPTION FOR BAYLOR TARGET ANTIGENS; NEW ANTIGENS

4.1Option for Baylor Target Antigens.

(a)Pursuant to the Original Agreement, Baylor granted to Cell Medica, for each Baylor Target Antigen (solely to the extent that Baylor Controls Technology Rights relating to such Baylor Target Antigen), an exclusive option to obtain the exclusive license set forth in Section 2.1(a) with respect to each Baylor Target Antigen (with respect to each Baylor Target Antigen, an “Antigen Option”).

(b)The Parties hereby acknowledge and agree that: (i) as of or prior to the Restatement Effective Date, Cell Medica has exercised, or has been deemed to have exercised, the Antigen Option with respect to the following two Baylor Target Antigens: (A) GD2, and (B) GPC3 (each, an “Exercised Baylor Target Antigen”), and (ii) no option or other payments are required or owed by Cell Medica in connection with any such exercised, or deemed exercised, Antigen Options for GD2 and GPC3. Accordingly, each of the Exercised Baylor Target Antigens are deemed a Licensed Antigen and (ii) all Baylor Target Patent Rights covering or disclosing any Modified NKT Product directed to an Exercised Baylor Target Antigen are included in the Licensed Core Technology Rights. The Parties further acknowledge and agree that Cell Medica did not exercise the Antigen Option with respect to the Baylor Target Antigen CSPG4 and such option for CSPG4 has expired.

Article V


PAYMENTS; CLOSING

5.1License Execution Fee. As consideration for the rights conveyed by Baylor under this Agreement, Cell Medica has paid Baylor a non-refundable total license fee (the “License Execution Fee”) comprising: (a) [*] in cash in immediately available funds by wire transfer to Baylor’s Account; and (b) certain BCM Preference Shares.

5.2through 5.12 [Intentionally Omitted].

5.13Royalty on Net Sales. Cell Medica shall pay Baylor the following royalties on a Licensed Product by Licensed Product, country by country, Calendar Year by Calendar Year, basis as set forth herein, subject to the terms and conditions of this Agreement:

(a)For Net Sales by Cell Medica or its Affiliates or sublicensees:

(i)up to [*] of Net Sales if such Licensed Product is covered by a Valid Claim in the country in which it is sold. Notwithstanding the foregoing, Cell Medica shall have the right to credit against such royalty amount owed under this Section 5.13(a)(i) for a particular Licensed Product any and each amount of royalties owed to Third Parties in consideration for a license to (1) any invention claimed in any Patent Rights controlled by such Third Party that has been incorporated, with the approval of the JSC under the

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Co-Development Agreement, or with the approval of Baylor after the expiration or termination of the Co-Development Agreement, into any such Licensed Product; and (2) any other Patent Rights necessary for the manufacture, use or sale or other commercialization of such Licensed Product (clauses (1) and (2), collectively, the “Third Party IP”), to the extent actually paid by Cell Medica or such Affiliate or by any sublicensee for such Licensed Product; provided, however that the Royalties paid to Baylor for the Net Sales of such Licensed Product shall not be less than one and three quarters of a percent (1.75%) of such Net Sales. Such reduction of Royalties allowed hereunder shall apply on an annual basis with no carryover of Third Party royalty balance from one calendar year to the following calendar year; or

(ii)greater than [*] of Net Sales if such Licensed Product is covered by a Valid Claim in the country in which it is sold. Notwithstanding the foregoing, Cell Medica shall have the right to credit against such royalty amount owed under this Section 5.13(a)(ii)  for a particular Licensed Product any and each amount of royalties owed to Third Parties in consideration for a license to any and all Third Party IP to the extent actually paid by Cell Medica or such Affiliate or by any sublicensee for such Licensed Product; provided, however that the Royalties paid to Baylor for the Net Sales of such Licensed Product shall not be less than [*] of such Net Sales. Such reduction of Royalties allowed hereunder shall apply on an annual basis with no carryover of Third Party royalty balance from one calendar year to the following calendar year; or

(iii)a royalty of [*] of Net Sales if such Licensed Product is not covered by a Valid Claim in the country in which it is sold, without any credit for royalties or other payments paid by Cell Medica or such Affiliate or such sublicensee to a Third Party. Notwithstanding the foregoing, Cell Medica shall have the right to credit against such royalty amount owed under this Section 5.13(a)(iii) for a particular Licensed Product any and each amount of royalties owed to Third Parties in consideration for a license to any and all Third Party IP to the extent actually paid by Cell Medica or such Affiliate or such sublicensee for such Licensed Product; provided, however that the Royalties paid to Baylor for the Net Sales of such Licensed Product shall not be less than [*] of such Net Sales. Such reduction of Royalties allowed hereunder shall apply on an annual basis with no carryover of Third Party royalty balance from one calendar year to the following calendar year. For clarity, if a Licensed Product is not covered by a Valid Claim in the country in which it is sold (and no such patents included within the Patent Rights issue in such country), then (unless sooner terminated as otherwise provided in Article XI) the day immediately following the tenth (10th) anniversary of the first commercial sale of such Licensed Product on behalf of or otherwise by Cell Medica in such country, [*] shall be owed thereafter to Baylor under this Section 5.13(a)(iii) for such Licensed Product in such country.

(b)Collectively the royalty payments that are the subject of this Section 5.13 are termed “Royalties” for purposes of this Agreement and shall be due and payable as provided in Article VI and delivered to Baylor in accordance with Section 5.16.

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5.14Milestone Payments.

(a)Amounts Owed.

(i)Cell Medica shall also pay Baylor a one-time milestone payment on each Licensed Product which is a Distinct Product, within the period of time specified in Section 5.14(d) after the achievement of the corresponding milestone event achieved as set forth in the chart below in this Section 5.14(a)(i) (such chart, the “Milestone Chart” and each such milestone event set out in the Milestone Chart, a “Milestone Event”), the amount of such milestone payment is specified in accordance with the Milestone Chart for such Milestone Event achieved, as of the time of achievement of such Milestone Event in, as applicable, the country or the supra-national jurisdiction, if applicable, where, the IND, BLA or corresponding non-U.S. regulatory application, as applicable, has been allowed or approved for such Distinct Product as of the time of achievement of such Milestone Event (each such milestone payment, a “Milestone Payment”). Notwithstanding anything contained herein to the contrary, each Milestone Payment shall only (A) apply to the first Distinct Product to achieve (if any) each Milestone Event specified in the Milestone Chart, and (B) be payable once regardless of the number of Distinct Products to achieve such Milestone Event.

Milestone Event #

Milestone Event

Milestone Payment
(for a Distinct Product)

1

Dosing of first patient in first Pivotal Clinical Trial of such a Distinct Product

$[*]

2

Approval by the FDA or EMA of the first Biological License Application (BLA) or Marketing Authorization Application (MAA) for such a Distinct Product (whichever occurs first, but not both)

$[*], but notwithstanding anything to the contrary herein, such Milestone Payment for the achievement of this Milestone Event 2 for such Distinct Product shall be paid within six (6) months after the First Commercial Sale (as defined below) of such Distinct Product to a Third Party: (A) in the U.S. (if this Milestone Event 2 was achieved by approval by the FDA), or (B) in France, Germany, the United Kingdom, Italy or Spain (if this Milestone Event 2 was achieved by approval by the EMA).

“First Commercial Sale” means, with respect to a

Distinct Product and country, the first sale to a Third Party of such Distinct Product in such country after marketing authorization and pricing approval has been obtained in such country.

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Milestone Event #

Milestone Event

Milestone Payment
(for a Distinct Product)

3

Completion of the first Calendar Year in which Net Sales by Cell Medica, its Affiliates and sublicensees, of such a Distinct Product exceed ]

$[*]

4

Completion of the first Calendar Year in which Net Sales by Cell Medica, its Affiliates and sublicensees, of such a Distinct Product exceed [*]

$[*]

5

Completion of the first Calendar Year in which Net Sales by Cell Medica, its Affiliates and sublicensees of such a Distinct Product exceed [*]

$[*]

6

Completion of the first Calendar Year in which Net Sales by Cell Medica, its Affiliates and sublicensees, of such a Distinct Product exceed $[*]

$[*]

 

(ii)For the avoidance of doubt, once a Milestone Payment listed in the Milestone Chart above (for Milestone Events 1 through 6) has been paid on a given Distinct Product, should the same Milestone Event (e.g., a second Pivotal Trial for another indication) be achieved, no additional Milestone Payment would be owed), subject solely to Section 5.14(b) with respect to SPP Indications.

(b)Adjustments for Small Patient Populations:

(i)As used herein, an “SPP Indication” means an indication for which the patient population for both the U.S. and the E.U., collectively, is estimated (by FDA, EMA, World Health Organization, Centers for Disease Control, or other similarly reputable medical authority) at less than 5,000 patients. If the Parties disagree with respect to the size of such patient population and cannot resolve such issue within thirty (30) days of undertaking to do so, then they shall engage a mutually agreeable Third Party expert to

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substantiate the estimated patient population. The costs of such expert shall be shared equally by the Parties, and such expert’s decision shall be binding upon the Parties.

(ii)If a Distinct Product that is being developed pursuant to this Agreement achieves Milestone Event 1 (Dosing of first patient in first Pivotal Clinical Trial) where such Pivotal Clinical Trial is being conducted for an SPP Indication (an “SPP Pivotal Clinical Trial”), then the Milestone Payment payable under Section 5.14(a) above for the achievement of Milestone Event 1 (the “Original Milestone 1 Payment Amount”) shall be reduced by [*]%) (such reduced amount, the “SPP Pivotal Trial Milestone Amount”). In such event, (A) if one or more SPP Pivotal Clinical Trials are subsequently initiated pursuant to this Agreement for such Distinct Product for different SPP Indications, then Cell Medica shall again pay Baylor the SPP Pivotal Trial Milestone Amount upon the dosing of the first patient in the first SPP Pivotal Clinical Trial for such different SPP Indication for up to three (3) such subsequent SPP Pivotal Clinical Trials; and (B) if a Pivotal Clinical Trial is subsequently initiated pursuant to this Agreement for such Distinct Product for an indication other than an SPP Indication, then Cell Medica shall pay Baylor an amount equal to (1) the Original Milestone 1 Payment Amount minus (2) the total of all other payments made by Cell Medica for such Distinct Product pursuant to this Section 5.14(b)(ii) (such amount, the “Milestone 1 Differential Amount”). For clarity, for each Distinct Product: (X) the payments made under this Section 5.14(b)(ii) (if any) are in lieu of any other payment to be made to Baylor for the achievement of Milestone Event 1 for such Distinct Product, subject to Section 5.14(b)(iv); (Y) in no event shall the total payments owed by Cell Medica to Baylor under this Section 5.14(b)(ii) exceed the Original Milestone 1 Payment Amount for such Distinct Product; and (Z) if Cell Medica makes the Milestone Differential Payment to Baylor under Section 5.14(b)(iv)  below for such Distinct Product, then no further payments shall be due to Baylor under this Section 5.14(b)(ii) with respect to such Distinct Product.

(iii)If a Distinct Product that is being developed pursuant to this Agreement achieves Milestone Event 2 (Approval of a BLA or MAA), where such approval is for an SPP Indication, then the Milestone Payment payable under Section  5.14(a) for the achievement of Milestone Event 2 (the “Original Milestone 2 Payment  Amount”) shall be reduced by [*]%) (such reduced amount, the “SPP Approval Milestone Amount”). In such Milestone Event, (A) if such Distinct Product subsequently receives BLA or MAA approval for a different SPP Indication, then Cell Medica shall again pay Baylor the SPP Approval Milestone Amount upon the receipt of BLA approval from the FDA or MAA approval from the EMA (whichever occurs first, but not both) for such Distinct Product for such SPP Indication for each of up to three (3) subsequent SPP Indications; and (B) if such Distinct Product receives BLA approval from the FDA or MAA approval from the EMA (whichever occurs first, but not both) for an indication other than an SPP Indication, then Cell Medica shall pay Baylor an amount equal to (1) the Original Milestone 2 Payment Amount minus (2) the total of all other payments made by Cell Medica for such Distinct Product pursuant to this Section 5.14(b)(iii) (the “Milestone 2 Differential Amount”). For clarity, for each Distinct Product: (X) the payments made under this Section 5.14(b)(iii) are in lieu of any other payment to be made to Baylor for the achievement of Milestone Event 2 for such Distinct Product, subject to Section 5.14(b)(iv); (Y) in no Milestone Event shall the total payments owed by Cell Medica to Baylor under this Section  5.14(b)(iii) exceed the Original Milestone 2 Payment Amount for such Distinct Product; and (Z) if Cell Medica

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makes the Milestone Differential Payment to Baylor under Section 5.14(b)(iv) for such Distinct Product, then no further payments shall be due to Baylor under this Section 5.14(b)(iii) with respect to such Distinct Product.

(iv)If a Distinct Product that has received BLA or MAA approval for an SPP Indication achieves Milestone Event 3 (annual Net Sales in excess of $[*]), and Cell Medica has made payments to Baylor under either or both of Section 5.14(b)(ii) and Section 5.14(b)(iii) for such Distinct Product, then in addition to the Milestone Payment to be made upon such achievement pursuant to Section 5.14(a) above, Cell Medica shall make a “Milestone Differential Payment” for such Distinct Product equal to the sum of (A) the Milestone 1 Differential Amount for such Distinct Product (if any), plus (B) the Milestone 2 Differential Amount for such Distinct Product (if any). The Milestone Differential Payment shall be made contemporaneously with Milestone Payment for Milestone Event 3.

(v)For purposes of this Section 5.14, the United Kingdom shall be deemed to be a member state of the E.U., regardless of any subsequent exit or withdrawal from the E.U. by the United Kingdom.

(c)[Intentionally Omitted.]

(d)Limitations. For the avoidance of doubt, the maximum amount of Milestone Payments that could potentially be payable by Cell Medica to Baylor under Section 5.14(a) or 5.14(b) if all of the Milestone Events (i.e., all of Milestone Events 1 through 6 set out in the Milestone Chart) are achieved (if any) is [*].

(e)Notification. Cell Medica shall notify Baylor in writing within thirty (30) days following the achievement of each Milestone Event (except with respect to Milestone Event 2 which shall be a longer period of time as set out in the Milestone Chart), such notice to be accompanied by payment of the appropriate Milestone Payment, where achieved by Cell Medica, and within ninety (90) days where such Milestone Event is achieved by any sublicensees of Cell Medica (except with respect to Milestone Event 2 which shall be a longer period of time as set out in the Milestone Chart). Each Milestone Event is to be paid regardless of whether Cell Medica or Cell Medica’s Affiliate or Cell Medica’s or its Affiliate’s sublicensee is the party achieving such Milestone Event, as provided above.

5.15Sublicensing Revenue Payments. In the event Cell Medica (or an Affiliate Sublicensee) grants any sublicenses its license to one or more of the Licensed Products under the Core Platform Patent Rights under this Agreement, Cell Medica (itself or through its Affiliate) agrees to pay to Baylor the following percentages of Sublicensing Revenue received by Cell Medica during the Sublicensing Revenue Period (each such share, the “Revenue Share”):

(a)[*] of all Sublicensing Revenue received by Cell Medica or an Affiliate Sublicensee from a Third Party Sublicensee of any Licensed Product(s) if such sublicense agreement is executed on or before the eighteenth (18th) month period immediately following the Restatement Effective Date (the “Initial 18-month Period”), provided that

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Cell Medica may credit against such Revenue Share (but only up to the amount of such Revenue Share) solely (and not more than) the amount equal to the sum of (i) [*] for each separate Licensed Core Product, if any, sublicensed to such Third Party Sublicensee in such transaction, plus (ii) that portion of any payments of Cell Medica to Baylor under the Co-Development Agreement (including, for the avoidance of doubt, under any Specific Industrial Research Agreement or Specific Industrial Clinical Research Agreement) allocable to the research and development of such sublicensed Licensed Product, if made between the Restatement Effective Date and such Initial 18-month Period;

(b)[*] all Sublicensing Revenue received by Cell Medica or an Affiliate Sublicensee from a Third Party Sublicensee of a Licensed Product(s) if such sublicense agreement is executed after the Initial 18-month Period and but within the three (3) year period immediately following the Restatement Effective Date, provided that Cell Medica may credit against such Revenue Share (but only up to the amount of such Revenue Share) solely (and not more than) the amount equal to the sum of (i) [*] for each separate Licensed Core Product, if any, sublicensed to such Third Party Sublicensee in such transaction, plus (ii) that portion of any payments of Cell Medica to Baylor under the Co-Development Agreement (including, for the avoidance of doubt, under any Specific Industrial Research Agreement or Specific Industrial Clinical Research Agreement) allocable to the research and development of such sublicensed Licensed Product, if made between such period after the Initial 18-month Period but within the three (3) year period immediately following the Restatement Effective Date; and

(c)[*] all Sublicensing Revenue received by Cell Medica or an Affiliate Sublicensee from a Third Party Sublicensee of a Licensed Product(s) if such sublicense agreement is executed after the third (3rd) anniversary of Restatement Effective Date but within the five (5) year period immediately following the Restatement Effective Date, provided that Cell Medica may credit against such Revenue Share (but only up to the amount of such Revenue Share) solely (and not more than) the amount equal to the sum of (i) [*] for each separate Licensed Core Product, if any, sublicensed to such Third Party Sublicensee in such transaction, plus (ii) that portion of any payments of Cell Medica to Baylor under the Co-Development Agreement (including, for the avoidance of doubt, under any Specific Industrial Research Agreement or Specific Industrial Clinical Research Agreement) allocable to the research and development of such sublicensed Licensed Product, if made between such period after the third (3rd) anniversary of the Restatement Effective Date but within the five (5) year period immediately following the Restatement Effective Date;

(d)In the event that Cell Medica or an Affiliate Sublicensee receives Sublicensing Revenue in a non-cash form, Cell Medica shall disclose the fair market value of the non-cash Sublicensing Revenue to Baylor. Baylor will not be entitled to receive any payments before Cell Medica has converted the non-cash consideration into a cash equivalent form. Cell Medica shall exercise good-faith efforts to convert the non-cash Sublicensing Revenue to a cash equivalent form as soon as reasonably possible.

5.16Payment Addresses. Payments shall be made by wire transfer at Cell Medica’s cost using wiring instructions provided in Schedule D. All payments shall

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reference the corresponding BLG number(s) listed under Article I or under Schedule D as updated.

Baylor Tax ID #: [*]

Baylor College of Medicine

Licensing Group

[*]Telephone No.[*]

Facsimile No.[*]

E-Mail[*]

Payments shall be deemed received only upon confirmation that all funds have been received by the Licensing Group as referenced above, which such confirmation shall be due immediately. Cell Medica hereby accepts responsibility for ensuring that payment is addressed correctly.

Cell Medica Payment Contact. For questions about payments, Baylor can contact Cell Medica at the address below:

Title[*]

Name:[*]Address[*]Telephone No.[*]

E-Mail[*]Each Party may update the contact information by written notice.

5.17Payment Conditions. All payments due hereunder are payable in United States dollars. Cell Medica is responsible for, and shall not deduct from any payment or impose on Baylor any transfer, exchange, collection or other charges related to any payment, including any wire transfer fees, and other than as expressly provided herein. For sales of Licensed Products in currencies other than the United States Dollar, Cell Medica shall use an exchange rate based upon the weighted average rate over the relevant time period, as such rates are published in The Wall Street Journal  during the period that such payment is due.

5.18Late Payments. Late payments shall be subject to a charge of [*] per month, the interest being compounded annually, or [*] U.S. dollars ($[*]) per month, whichever is greater. Cell Medica shall calculate the correct late payment charge, and shall add it to each such late payment. Such late payment charge and the payment and acceptance thereof shall not negate or waive the right of Baylor to seek any other remedy, legal or equitable, to which it may be entitled because of the delinquency of any payment. Cell Medica shall indemnify Baylor for all attorneys’ fees and costs Baylor incurs in obtaining a full payment of that which is owed to Baylor.

5.19No Precedent. The Parties agree that the amount or rate of any fee, royalty, payment, or consideration under this Agreement is based on the particular circumstances of this transaction, shall not be deemed to be a precedent for any other transaction, whether between the Parties or of any Third Party, or in connection with any rights or remedies asserted by Baylor, and shall not be deemed to be an indication of what

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constitutes or may constitute, or be used in the determination of, a maximum reasonable royalty regarding any Patent Right or Licensed Technology.

5.20No Double Payment. To the extent any Distinct Product for which a given Milestone Payment or Royalties on the Net Sales of such Distinct Product hereunder is owed is both a Licensed Core Product and a Licensed Future Oncology Product and/or Licensed Future Non-Oncology Product, such Milestone Payment shall be owed only once, and a Royalty for any Net Sales of such Distinct Product shall be owed only once for the same Net Sales, provided that such Milestone Payment and such Royalty owed for such Distinct Product is at the highest rate for which such Distinct Product qualifies. For the avoidance of doubt, a separate Milestone Payment and separate Royalties shall be owed for a different Distinct Product even if such Distinct Product and one or more other Distinct Products utilize, or are covered by the same Technology Rights.

Article VI
REPORTING

6.1Annual Progress Report. No later than sixty (60) days after December 31 of each Calendar Year, for each Licensed Product following completion of its FIM Study, Cell Medica shall provide to Baylor a written annual progress report describing progress on all research and development and commercial activities with respect to such Licensed Product, during the most recent twelve (12) month period ending December 31 and plans for the forthcoming year (“Annual Progress Report”). If multiple Licensed Products are covered by the license granted under this Agreement, the progress report shall provide the information set forth above for each Licensed Product. At Baylor’s request, Cell Medica shall also provide and shall cause its Affiliates and sublicensees to provide any reasonable additional data Baylor requires to evaluate Cell Medica’s performance of its obligations hereunder.

6.2Notification of First Sale. For each Licensed Product, Cell Medica shall notify Baylor of the date on which Cell Medica, its Affiliates, and/or its sublicensees makes the first sale of such Licensed Product within thirty (30) days of occurrence. Thereafter, with respect to such Licensed Product, Cell Medica shall notify Baylor of the date of the first sale of such Licensed Product in each country in which it occurs within (a) thirty (30) days of occurrence where such first sale is made by Cell Medica or its Affiliates, or (b) thirty (30) days of Cell Medica’s being notified of such first sale, where such first sale is made by a sublicensee.

6.3Royalty Reports. Following the first commercial sale of a Licensed Product, Cell Medica shall submit to Baylor within sixty (60) days after March 31, June 30, September 30 and December 31, a written report with respect to such Licensed Product on a form provided by Baylor (a current version of which is attached as Schedule E) setting forth for such calendar quarter at least the following information, to the extent Cell Medica, its Affiliates, and/or sublicensees possesses or can obtain such information:

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(i)the number of units such Licensed Product sold by Cell Medica, its Affiliates, and sublicensees in each country;

(ii)total billings for such Licensed Product sold by Cell Medica, its Affiliates, and sublicensees in each country;

(iii)the gross amount of monies or cash equivalent or other consideration which is received for sales, leases, licenses or other modes of transfer of Licensed Products by Cell Medica, its Affiliates, and sublicensees;

(iv)the identity of that consideration which is received instead of money for sales, leases, licenses or other modes of transfer of Licensed Products by Cell Medica, its Affiliates, and sublicensees;

(v)deductions from the gross amount as expressly permitted herein to determine the Net Sales thereof;

(b)the Third Party royalty, milestone or other payments for which Cell Medica is seeking a credit under Section 5.13;

(c)the amount of Royalties due thereon, or, if no Royalties are due to Baylor for any reporting period, the statement that no Royalties are due;

(d)the amount of Sublicensing Revenue received by each of Cell Medica and any Affiliate Sublicensee from its sublicensee(s); and

(e)the amount of other payments due Baylor, including milestone payments.

The royalty report shall be certified as correct by an officer of Cell Medica. After termination or expiration of this Agreement, Cell Medica will continue to submit royalty reports and Royalty (and if the Sublicensing Revenue Period has not yet expired, Sublicensing Revenue) payments to Baylor until all Licensed Products made, used, marketed, leased or imported under this Agreement have been sold. In the event a Released Product is licensed to a Third Party, Baylor shall provide to Cell Medica a report on the sales of such product and royalties or other payments due thereon to Cell Medica, in nature and substance as set forth in this Section 6.3.

6.4Payment to Accompany Royalty Reports. Cell Medica shall pay to Baylor with each such royalty report the amount of Royalties and other payments due with respect to such calendar quarter. If multiple technologies are covered by the license granted hereunder, Cell Medica shall specify which Licensed Product and Patent Rights are utilized for each Licensed Product included in the royalty report by citing the applicable BLG number listed under Article I of this Agreement or under Schedule C as updated from time to time by Baylor.

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6.5Notification of Merger or Acquisition. In the event of any acquisition, merger, consolidation, change of corporate name, or Change of Control, Cell Medica shall notify Baylor in writing within ten (10) days of the COC Closing or closing of the event otherwise.

6.6Entity Status. If Cell Medica, its Affiliate, or a sublicensee does not qualify as a “small business entity” as provided by the United States Patent and Trademark Office, Cell Medica must notify Baylor immediately.

Article VII
RECORDS AND INSPECTION

7.1Accounting Records. Cell Medica shall maintain, and shall cause its sublicensees to maintain, complete and accurate records relating to the rights and obligations under this Agreement and any amounts payable to Baylor in relation to this Agreement, which records shall contain sufficient information to permit Baylor to confirm the accuracy of any reports delivered to Baylor and compliance in other respects with this Agreement. The relevant party shall retain such records for at least three (3) years following the end of the Calendar Year to which they pertain.

7.2Audit by Baylor. During the Term and for a period of two (2) years thereafter, Baylor or its representatives shall have the right to inspect the books and records of Cell Medica in conjunction with the performance of Cell Medica’s obligations under the terms and conditions of this Agreement, such right to inspect exercisable, absent cause for more frequent inspection, no more than once each twelve (12) month period and upon reasonable notice. The scope of such audit and inspection activities may include the review of records supporting activities performed by Cell Medica in conjunction with its obligations under this Agreement, as well as processes and related process internal controls and support systems, the quality and accuracy of which are directly related to the performance of Cell Medica’s obligations under the terms and conditions of this Agreement. Cell Medica agrees to provide representatives of Baylor reasonable access to books, records, systems and processes, and shall cooperate fully with Baylor’s representatives in support of their inspection and audit activities during Cell Medica’s normal business hours.

7.3Payment Deficiency. If a payment deficiency is determined, Cell Medica its Affiliate Sublicensee(s), and its Third Party Sublicensee(s), as applicable, shall pay the outstanding amounts within thirty (30) days of receiving written notice thereof, plus interest on such outstanding amounts as described in Article V.

7.4Responsibility for Audit Costs. Baylor will pay for any audit done under Section 7.2. However, in the event that the audit reveals an underpayment of Royalties or fees by more than five percent (5%) for the period being audited, the cost of the audit shall be paid by Cell Medica. If the underpayment is less than five percent (5%) but more than two percent (2%) for the period being audited, Cell Medica and Baylor shall each pay fifty percent (50%) of the cost of the audit. Cell Medica shall reimburse Baylor for all attorneys’ fees and costs Baylor incurs in obtaining access to conduct the audit and

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collecting, when applicable, for the cost of the audit and any underpaid amounts and interest.

Article VIII
SUBLICENSES

8.1Cell Medica Sublicensees.

(a)All sublicenses granted by Cell Medica (or any Affiliate Sublicensee) of its rights hereunder shall be subject to the terms of this Agreement. Cell Medica shall be responsible for its sublicensees’ compliance with this Agreement and shall not grant any rights which are inconsistent with the rights granted to and obligations of Cell Medica hereunder. Any act or omission of a sublicensee of Cell Medica which would be a breach of this Agreement if performed by Cell Medica shall be deemed to be a breach by Cell Medica of this Agreement (a “Sublicensee Breach”), but notwithstanding anything to the contrary contained in this Agreement, a Sublicensee Breach shall not trigger any right for Baylor to terminate this Agreement (in part or whole) or any other termination right under this Agreement. In the event of any uncured Sublicensee Breach, Cell Medica shall notify Baylor (promptly after it has actual knowledge) of such Sublicensee Breach and shall act in good faith and in its reasonable business judgment to enforce its rights under its agreement with such sublicensee with respect to such Sublicensee Breach. If (i) such Sublicensee Breach remains uncured after any applicable notice and cure period in Cell Medica’s sublicense agreement with a sublicensee and (ii) such Sublicensee Breach causes or is reasonably likely to cause material harm to Baylor or its reputation, Cell Medica shall terminate such sublicense agreement.

(b)In connection with the 2020 Transaction, Baylor hereby consents to a sublicense of the rights granted under Section 2.1 relating to Licensed Core Technology, Licensed Core Products, and Baylor Target Antigens from Cell Medica to an Affiliate Sublicensee as of the Restatement Effective Date or within a reasonable period of time thereafter (but in no event more than three (3) months after the Restatement Effective Date). Any additional sublicenses from Cell Medical to an Affiliate Sublicensee shall be subject to Baylor’s prior consent, which will not be unreasonably withheld, delayed or conditioned.

8.2Baylor Audit Right. Each sublicense agreement granted by Cell Medica (and/or its Affiliate Sublicensee) shall include an audit right by Baylor of the same scope as provided in this Article VIII hereof with respect to Cell Medica and provide that Baylor is an intended Third Party beneficiary regarding such audit right. Each sublicense agreement shall expressly state that it and the sublicenses granted thereunder terminate automatically upon the expiration (but not the early termination) of, and no sublicense agreement shall contain any provision which would cause it to extend beyond the Term of this Agreement as defined below (except with respect to those terms and conditions which are specifically identified as surviving the termination or expiration of the Agreement). Cell Medica shall give Baylor prompt notification of the identity and address of each sublicensee with whom it concludes a sublicense agreement and shall supply

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Baylor with a copy of each such sublicense agreement (redacted solely to the extent necessary to withhold confidential information of such sublicensee).

8.3Service Provider Sublicensees. For clarity, agreements in which Cell Medica, its Affiliates or its sublicensees granted limited sublicenses to service providers (including, without limitation, CROs, contract manufacturers and clinical sites) solely for the purpose of providing services to Cell Medica, Affiliates or its sublicensees in furtherance of the purposes of this Agreement, and which do not grant the service provider any right to use any Technology Right licensed by Baylor hereunder for any other purpose, shall not be subject to Section 8.2, but shall be subject to Sections 8.1 and 8.4. Cell Medica shall use reasonable efforts to maintain an accurate list of all such sublicensees described in this Section 8.3, and shall provide such list to Baylor at least annually.

8.4Enforcement. Cell Medica shall enforce or assist Baylor with enforcing any of the provisions mentioned above in this Article VIII against a sublicensee.

Article IX
PATENTS AND INFRINGEMENT

9.1Patent Prosecution Responsibility.

(a)Core Platform Patent Rights; Baylor Target Patent Rights; Other Licensed Technology Patent Rights. Cell Medica shall have the right to file, prosecute, and maintain, shall be responsible for filing, prosecuting and maintaining, and shall file, prosecute, and maintain all patent applications and patents included in the Core Platform Patent Rights and, (i) if Cell Medica exercises its option under Section 3.1 with respect to a Future Oncology Invention, the Future Oncology Patent Rights covering such Future Oncology Invention, (ii) if Cell Medica exercises its option under Section 3.2 with respect to a Future Non-Oncology Invention, the Future Non-Oncology Patent Rights covering such Future Non-Oncology Invention, and (iii) if Cell Medica exercises its option pursuant to Section 4.1 with respect to a Baylor Target Antigen, the Baylor Target Patent Rights disclosing or covering such Baylor Target Antigen, and Cell Medica agrees to pay all Legal Costs associated therewith, except as set forth below in Section 9.2. Cell Medica shall select all outside counsel for prosecution of such Patent Rights, which such counsel shall be reasonably acceptable to Baylor. Such patent counsel shall invoice Cell Medica directly for all such Legal Costs.

(b)Future Patent Rights. Baylor shall have the right of, and be responsible for filing, prosecuting and maintaining all patent applications and patents included in the Future Oncology Patent Rights and Future Non-Oncology Patent Rights and Cell Medica agrees to pay and shall pay all Legal Costs associated therewith, except as set forth below in this Section 9.1(b). Baylor shall select all outside counsel for prosecution of such Patent Rights, which counsel shall be reasonably acceptable to Cell Medica. Such patent counsel shall invoice Cell Medica directly for all such Legal Costs, provided that Cell Medica’s responsibility for such Legal Costs shall be reduced on a pro-

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rata basis should Baylor license such Patent Rights for fields of use not licensed to Cell Medica to one or more Third Parties, to the extent permitted hereunder. Upon exercise by Cell Medica of its option under Section 3.1 or 3.2 with respect to a Future Oncology Invention or Future Non-Oncology Invention, Baylor’s rights under this Section 9.1(b) shall cease with respect to such Future Oncology Invention or Future Non-Oncology Invention, and the continued prosecution and maintenance of any Patent Rights claiming such product or invention, shall be Cell Medica’s right, pursuant to Section 9.1(a), provided that for any Patent Rights covering more subject matter than the optioned Future Oncology Invention or Future Non-Oncology Invention, Baylor shall be given sufficient time to arrange for a separate filing for such non-optioned subject matter, provided that the prosecution of such separate filing shall be conducted in a manner that will not adversely affect the validity, scope or enforceability of the patent filings for the optioned subject matter.

(c)Prosecution Diligence. With regard to any patent application or patent that Cell Medica shall or may file, prosecute, or maintain under this Section  9.1, Cell Medica

(i)shall file, prosecute, or maintain such patent application or patent diligently and in good faith,

(ii)shall not unreasonably or in bad faith delay the filing of such patent application,

(iii)shall not fail to meet any deadlines or payment obligations required for the continued prosecution of such patent application, and

(iv)shall in good faith and using its diligent efforts file, prosecute, and maintain at least one Valid Claim in at least one patent application or patent covering each Distinct Product.

Any delay or failure to file or prosecute any patent application or to maintain any patent to avoid the coming into existence of a Valid Claim for purposes of avoiding the payment of a Milestone Payment or Royalty shall be deemed to be unreasonable and in bad faith.

9.2Notification of Intent Not to Pursue. In the event that Cell Medica decides not to pay for the Legal Costs associated with either: (i) the prosecution to issuance of the Core Platform Patent Rights, Baylor Target Patent Rights, Future Oncology Patent Rights and/or Future Non-Oncology Patent Rights or (ii) the maintenance of any United States or foreign application or issued patent within such Patent Rights, Cell Medica shall timely notify Baylor in writing thereof. Cell Medica’s right under this Agreement to practice the invention under such Patent Right under Article II and/or Article IV and to prosecute such Patent Right under Section 9.1 shall immediately terminate upon the giving of such notice. If Cell Medica fails to notify Baylor in sufficient time for Baylor to assume said costs prior to the abandonment or expiration of any such Patent Rights by Cell Medica in a country, Cell Medica shall be considered in material breach of this Agreement with respect to the Licensed Products affected by such Patent Rights in such country.

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9.3Notification of Patent Prosecution Action. Each Party agrees to keep the other Party fully informed of all prosecutions and other actions for which it is responsible pursuant to this Article IX, including submitting to such other Party copies of all official actions and responses thereto, and agrees to take into consideration, in good faith, all reasonable comments of such other Party with respect thereto. The Party responsible for prosecution of any Patent Rights under this Article IX shall use all reasonable efforts to amend any patent application to include claims reasonably requested by such other to protect the products to be sold and technologies to be used under this Agreement and to file and prosecute patents in foreign countries indicated by and paid for by Cell Medica.

9.4Cooperation. Baylor agrees to reasonably cooperate with Cell Medica to whatever extent is reasonably necessary and in compliance with applicable law to provide Cell Medica the full benefit of the license granted herein.

9.5Infringement Action Procedures. During the Term of this Agreement as defined below, each Party shall promptly inform the other of any suspected infringement of any claims in the Core Platform Patent Rights, Baylor Target Patent Rights (to the extent included in Cell Medica’s licenses hereunder), Future Oncology Patent Rights, or Future Non-Oncology Patent Rights (the “Implicated Patent Rights”) or the misuse, misappropriation, theft or breach of confidence of other proprietary rights in the Licensed Technology and/or the Implicated Patent Rights by a Third Party, and with respect to such activities as are suspected. Any action or proceeding against such Third Party shall be instituted as following:

(a)Baylor and Cell Medica shall discuss in good faith whether to jointly institute an action for infringement, misuse, misappropriation, theft or breach of confidence of the proprietary rights against such Third Party. Such joint action shall be brought in the names of both Baylor and Cell Medica. If Baylor or Cell Medica decides to jointly prosecute an action or proceeding after it has been instituted by the other Party, the action shall be continued in the name or names they both agree is expedient for efficient prosecution of such action. Cell Medica and Baylor shall agree to the manner in which they shall exercise control over any joint action or proceeding against such Third Party. If the Parties cannot agree after a period of 10 days, then Cell Medica may proceed under Section 9.5(b) below against such Third Party (but not any other Third Party). In such joint action or proceeding, the out-of-pocket costs and any recovery or settlement shall be shared equally.

(b)If the Parties do not agree to participate in a joint action or proceeding as contemplated under Section 9.5(a) against a Third Party, then Cell Medica shall have the first right, but not the obligation, solely to institute such an action for infringement of the Implicated Patent Rights, or misuse, misappropriation, theft or breach of confidence of the proprietary rights against such Third Party. If Cell Medica fails to bring such an action or proceeding within a period of three (3) months after receiving notice or otherwise having knowledge of such infringement, then Baylor shall have the right, but not the obligation, solely to prosecute the same at its own expense; and the other Party will reasonably cooperate with such Party prosecuting such action in prosecuting such action. Baylor’s cooperation in an action brought by Cell Medica under this Section 9.5(b) in

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accordance with Section  9.4 shall be at Cell Medica’s sole expense. Should either Baylor or Cell Medica commence action under the provisions of this Section 9.5 and thereafter elect to abandon the same, it shall give timely notice to the other Party who may, if it so desires, continue prosecution of such action or proceeding. All recoveries, whether by judgment, award, decree or settlement, from infringement or misuse of Licensed Technology and/or any Implicated Patent Rights by a Party under Section 9.5(a) and this Section 9.5(b) shall be apportioned as follows: (i) the Party bringing the action or proceeding (the “Prosecuting Party”) shall first recover an amount equal to the costs and expenses incurred by such Prosecuting Party directly related to the prosecution of such action or proceeding, including any amounts actually paid by the Prosecuting Party to the other Party (the “Non-Prosecuting Party”) to the extent such amount reimburses the Non-Prosecuting Party for its costs and expenses incurred in the prosecution of such action or proceeding; (ii) the Non-Prosecuting Party in such action or proceeding shall then recover costs and expenses incurred by the Non-Prosecuting Party, if any, directly related to its cooperation in the prosecution of such action or proceeding and not otherwise previously reimbursed by the Prosecuting Party to the Non-Prosecuting Party and deducted under clause (i); and (the remainder, if any, shall be shared as follows: (x) seventy-five percent (75%) the Prosecuting Party, and twenty-five percent (25%) the Non-Prosecuting Party.

(c)Neither Baylor nor Cell Medica will notify a possible infringer of infringement or put such infringer on notice of the existence of any Implicated Patent Rights without first obtaining consent of the other, not to be unreasonably withheld or delayed.

9.6Consent to Settle. Neither Baylor nor Cell Medica shall settle any action covered by Section 9.5 without first obtaining the consent of the other Party, which consent will not be unreasonably withheld or delayed.

9.7Liability for Losses. Baylor shall not be liable for any losses incurred as the result of an action for infringement brought against Cell Medica as the result of Cell Medica’s exercise of any right granted under this Agreement.

9.8Patent Term Extension. Cell Medica shall apply for an extension of the term of any patent included within the Implicated Patent Rights if appropriate under the Drug Price Competition and Patent Term Restoration Act of 1984 and/or European, Japanese and other foreign counterparts of such law. Cell Medica shall prepare all documents, and Baylor agrees to execute the documents and to take additional action as Cell Medica reasonably requests in connection therewith.

Article X
TERM

Unless sooner terminated as otherwise provided in Article XI: (a) the licenses to Patent Rights and other licensed Technology Rights granted herein under the respective grants in Article II shall expire on a country-by-country basis, on the later of (i) the date of

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expiration of the last of such Patent Rights issued in such country licensed to Cell Medica under this Agreement to expire or (ii) in the event that no patents included within the Patent Rights issue in such country, the day immediately following the tenth (10th) anniversary of the first commercial sale of Licensed Products by Cell Medica in such country; and (b) after such expiration, but not any early termination by Baylor pursuant to Article XI of this Agreement, Cell Medica shall have a perpetual, irrevocable, paid-in-full (i.e., royalty free) licenses in such country under the licenses granted by Baylor to Cell Medica hereunder, including as set out in Sections 2.1, 2.2 and 2.3.

Article XI
AGREEMENT TERMINATION

11.1Termination by Baylor for Default.

(a)On Product by Product Basis

(i)This Agreement shall immediately terminate solely with respect to a Distinct Product upon the written notification by Cell Medica that it is discontinuing funding to support Baylor’s Exclusive Academic Partner Early R&D Participation Rights with respect to said Distinct Product.

(ii)Baylor may terminate this Agreement solely with respect to a Distinct Product in the event of a material default or material failure by Cell Medica to perform any of the terms, covenants or provisions of this Agreement, including failure to make timely payment, and including a breach of its obligations under Section  2.6(a) regarding Baylor’s Exclusive Academic Partner Early R&D Participation Rights (and provided such failure to comply was not due to the fault of Baylor or its employees or agents), with respect to such Distinct Product (a “Product-Related Breach”), unless Cell Medica, within sixty (60) days after delivery of written notice of termination by Baylor identifying such Product-Related Breach, cures such alleged Product-Related Breach.

(iii)Notwithstanding Section 11.1(a)(i), if:

(1)(A) the same type of Product-Related Breach has occurred three (3) times or more with regard to such Distinct Product during the immediately preceding twelve (12) months and (B) Baylor has duly notified Cell Medica in writing of each such Product-Related Breach,

(2)but (A) Baylor has not given written notice of termination therefor or (B) termination of this Agreement with respect to such Product-Related Breach has been avoided by cure thereof, and

(3)Baylor can demonstrate that the pattern of such Product-Related Breaches (as cured by Cell Medica) is causing Baylor material and on-going harm,

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then Cell Medica shall not have any further right to cure any further Product-Related Breaches.

(iv)Termination of this Agreement with respect to such Distinct Product shall be effective

(1)at the end of such sixty (60)-day period if Cell Medica has the right to cure such Product-Related Breach and such Product-Related Breach is not cured within such sixty (60)-day period, provided that if Cell Medica initiates the dispute resolution proceedings under Article XIV during such sixty (60)-day period, then the termination by Baylor shall not be effective unless and until (A) a final determination is made under Article XIV that Cell Medica so committed such Product-Related Breach, and thereafter (B) Cell Medica then fails to cure such Product-Related Breach within sixty (60) days after such final determination, or

(2)upon written notice by Baylor if Cell Medica has no right to cure pursuant to Section 11.1(a)(ii), provided that if Cell Medica initiates the dispute resolution proceedings under Article XIV within thirty (30) days of receipt of such written notice by Baylor, then the termination by Baylor shall not be effective unless and until a final determination is made under Article XIV whether the requirements of Section 11.(a)(ii) have been met.

(b)Entire Agreement. This Agreement shall immediately terminate in its entirety upon the written notification by Cell Medica that it is discontinuing all funding to support Baylor’s Exclusive Academic Partner Early R&D Participation Rights. Baylor may terminate this Agreement in its entirety in the event that, at any time during the period from the Effective Date until the end of the sixth anniversary of the Effective Date: Cell Medica fails to pay at least ninety percent (90%) of all of the amounts due to Baylor; or (ii) Cell Medica fails to comply with its obligations under Section 2.6 regarding Baylor’s Exclusive Academic Partner Early R&D Participation Rights (provided such failure to comply was not caused by the fault of Baylor or its employees or agents to comply with Baylor’s obligations under this Agreement or the Co-Development Agreement or any Specific Industrial Research Agreement or Specific Industrial Clinical Research Agreement) with respect to eighty percent (80%) of the Licensed Core Products or Future Products as to which Early R&D Activities applied (each, an “Essential Breach”), unless Cell Medica, within sixty (60) days after Baylor giving written notice of termination identifying such Essential Breach, cures such alleged Essential Breach (an “Essential Breach Cure”). The termination of this Agreement in its entirety shall be effective at the end of such sixty (60)-day period if such Essential Breach is not cured within such sixty (60)-day period; provided that if Cell Medica initiates the dispute resolution proceedings under Article XIV during such sixty (60)-day period, then the termination by Baylor shall not be effective unless and until a final determination is made under Article XIV that Cell Medica so committed such Essential Breach and Cell Medica fails to cure such Essential Breach within sixty (60) days after such decision.

(c)For the avoidance of doubt, Cell Medica shall remain liable for any and all amounts due under this Agreement until such amounts are paid and this obligation

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shall survive termination date of this Agreement. The failure of Baylor to exercise such right of termination, for non-payment of Royalties, fees or otherwise, shall not be deemed to be a waiver of any right Baylor might have, nor shall such failure preclude Baylor from exercising or enforcing said right upon any subsequent failure by Cell Medica.

11.2Termination by Baylor for Cell Medica Insolvency. Baylor shall have the right, at its option, to cancel and terminate this Agreement in the event that Cell Medica shall (i) become the defendant in insolvency, dissolution, bankruptcy or receivership proceedings affecting the operation of its business or (ii) make an assignment of all or substantially all of its assets for the benefit of creditors, or in the event that (iii) a receiver or trustee is appointed for Cell Medica and Cell Medica shall, after the expiration of thirty (30) days following any of the events enumerated above, have been unable to secure a dismissal, stay or other suspension of such proceedings.

11.3[Intentionally Omitted].

11.4Termination by Cell Medica. Cell Medica shall have the right in its sole discretion to terminate this Agreement, on a Distinct Product by Distinct Product and/or country by country basis, upon sixty (60) days’ written notice to Baylor (it being understood that a termination of its license to an individual Distinct Product shall not be a termination in its entirety to the applicable Licensed Technology employed or utilized in connection therewith except to extent that no other Distinct Product also employs or utilizes such Licensed Technology). For the avoidance of doubt, if Cell Medica terminates its rights to all Distinct Products in all countries in the Territory, this Agreement shall terminate in its entirety, subject to the survival provisions of Section  11.8.

11.5Effects of Agreement Termination.

(a)Termination of a Distinct Product or Country. In the event of early termination of this Agreement (i) by Baylor with respect to a Distinct Product pursuant to Section 11.1(a) or in its entirety pursuant to Section 11.1(b), 11.2 or 11.3, or (ii) by Cell Medica pursuant to Section 11.4 with respect to a Distinct Product or country or in its entirety, the following shall apply:

(i)where such termination is as to this Agreement in its entirety, all options and all licenses granted hereunder shall end and terminate, and all rights to the Licensed Products and related Technology Rights licensed to Cell Medica shall revert to Baylor, and, as provided for in the Co-Development Agreement, the Co-Development Agreement shall also terminate; and

(ii)where such termination is only with respect to a Distinct Product or country, all licenses and options to license granted hereunder with respect to such terminated Distinct Product or country shall end and terminate, and all Technology Rights either licensed to Cell Medica as of such time, or, with respect to a terminated Distinct Product, to which Cell Medica has an option to license as of such time, covering or included in such terminated Distinct Product (and only such Distinct Products) shall revert or be retained, as the case may be, to Baylor with respect to such country(ies) (the

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Technology Rights described in this subsection (ii) together with the Technology Rights described in Section 11.5(a)(i), “Terminated Technology Rights”.

(b)Effect of Termination. At the effective date of any such termination of this Agreement with respect to a Distinct Product (or if this Agreement is terminated in its entirety, then with respect to all Distinct Products), Cell Medica shall immediately cease using any such terminated Distinct Product(s) and Terminated Technology Rights and Cell Medica shall immediately destroy the terminated Distinct Product(s) (except where otherwise required by any Regulatory Authority), and send to Baylor a written affirmation of such destruction signed by an officer of Cell Medica; provided, however, that Cell Medica, its Affiliates or its sublicensees may sell any units of such terminated products actually in the possession of Cell Medica (or its Affiliates, sublicensees or contract manufacturers) on the date of termination, provided that Cell Medica continues to submit royalty reports to Baylor and pays to Baylor the Royalties on all such sales in accordance with Section 5.13 with respect thereto and otherwise complying with the terms of this Agreement.

(c)For clarity, if Cell Medica terminates, or otherwise discontinues its license rights, or if Baylor terminates such rights or the option to obtain a license to any Distinct Product or Baylor Target Antigen, Cell Medica shall lose its rights with respect to any Valid Claim covering such Distinct Product or Baylor Target Antigen or, in each case, its manufacture, but only solely as such Valid Claim covers such terminated product, and not as to other Licensed Core Product or Future Oncology Product or Future Non-Oncology Product which are not being terminated.

11.6Effect of Termination on Sublicensees. Notwithstanding Sections 11.1  through 11.5, upon expiration or termination of this Agreement for any reason in its entirety or with respect to a Distinct Product,

(a)Cell Medica shall promptly send notice of such termination to each of its sublicensees; and

(b)each sublicense then-granted by Cell Medica to a sublicensee shall remain in effect as a direct license from Baylor to the sublicensee (each a “New License Agreement”), for the scope of the license granted to such sublicensee, either, as elected by Baylor, at its sole discretion:

(i)on the same terms as the relevant sublicense agreement (as and to the extent they relate to the sublicense of rights licensed to Cell Medica hereunder); or

(ii)the terms of this Agreement;

in each case, provided (x) that the sublicensee is not at the time of such termination (aa) in breach of its sublicense agreement and (bb) culpable for any breach by Cell Medica under Section 11.1 through 11.4, and (y) that the financial terms of each New License Agreement shall be identical to the corresponding financial terms of the relevant sublicense agreement or this Agreement. In the event of termination of this Agreement

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and if Baylor grants a direct license to any sublicensee pursuant to the preceding sentence, Baylor will not be bound by any grant of rights broader than or will not be required to perform any obligation other than those rights and obligations contained in this Agreement. Baylor and the sublicensee will modify each such New License Agreement to include all of the rights of Baylor that are contained in the sublicense agreement or this Agreement, as elected by Baylor, at its sole discretion. Notwithstanding the foregoing, each sublicensee’s right to a New License Agreement shall only be available to the extent (i) Cell Medica has provided Baylor with a copy of the sublicense agreement granting the sublicense to such Sublicensee as required under Article VIII and with all terms relating to the rights and obligations under this Agreement left unredacted, (ii) such sublicensee notifies Baylor within ninety (90) days after the termination of this Agreement that it wishes to enter into a New License Agreement, (iii) the obligations and/or duties of Baylor under the New License Agreement will not be greater than the obligations and/or duties of Baylor under this Agreement and (v) there is no outstanding or ongoing material breach of such sublicense by such sublicensee which remains uncured.

11.7No Refund. Baylor is under no obligation to refund any payments made by Cell Medica to Baylor prior to the effective date of such termination or expiration, including, without limitation, in the event this Agreement is terminated pursuant to this Article XI or expires as provided for in Article X.

11.8Survival of Termination. No termination of this Agreement shall constitute a termination or a waiver of any rights of either Party against the other Party accruing at or prior to the time of such termination. The obligations of Sections 11.5, 11.6, 11.7, 11.8, 16.1, 16.2, 16.3, and 16.4, and Articles VII (as stated therein), XIV, XV, XVII and XVIII shall survive termination of this Agreement, and any other provisions of this Agreement that by their nature are necessary to survive the expiration or other termination of this Agreement shall survive the expiration or other termination of this Agreement. Subject to the immediately preceding sentence, any provision in this Agreement related to (a) any royalty that is owed and due under this Agreement as of the effective date of termination or thereafter pursuant to Section  11.5(b), or (b) any Milestone Payment that is owed and due under this Agreement as of the effective date of termination shall survive termination of this Agreement for as long as such royalty or Milestone Payment is unpaid.

Article XII
ASSIGNMENT

Neither Party may assign or otherwise transfer this Agreement or any of its rights or obligations hereunder (either in whole or in part) to any person without the prior written consent of the other Party, or delegate any of its rights or obligations hereunder. Notwithstanding the foregoing, however, Cell Medica may delegate any of its rights or obligations hereunder and may assign or otherwise transfer this Agreement and its rights and obligations hereunder, either in whole or in part, without Baylor’s consent: (a) in connection with any Change of Control, or the transfer or sale of all or substantially all of the assets, or the business of, Cell Medica to which this Agreement relates, or (b) to any

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Affiliate (and, for clarity, to a New Cell Medica Group Topco); so long as Cell Medica gives Baylor prompt notice of such action and the assignee or successor entity or Affiliate, as the case may be, acknowledges its consent and agreement to the terms of this Agreement and the License and Option Agreement (and, if and as applicable all SIRAs and SICRAs in effect at such time) in writing before such assignment; and so long as such action is not entered into solely to satisfy creditors of Cell Medica. This Agreement shall be binding upon and shall inure to the benefit of the Parties and each of their respective successors, legal representatives and assignees. Any attempted assignment or other transfer of this Agreement not effected in accordance with this Article XII shall be null and void.

Article XIII
GOVERNMENTAL COMPLIANCE

13.1Compliance with Applicable Laws. Cell Medica shall at all times during the Term of this Agreement and for so long as it shall use the Licensed Technology and/or Patent Rights, or sell Licensed Products, comply and cause its sublicensees to comply with all laws that may control or apply to the import, export, manufacture, use, sale, marketing, distribution and other commercial exploitation of the Licensed Technology, Patent Rights, Licensed Products or any other activity undertaken pursuant to this Agreement.

13.2Requirement for U.S. Manufacture. Cell Medica agrees that, to the extent required under 37 CFR 401 and as applicable to a particular Licensed Product depending on the funding for the Core Subject Technology incorporated therein prior to the Effective Date, such Licensed Product leased or sold in the United States shall be manufactured substantially in the United States, and Baylor agrees to, upon request of Cell Medica, assist Cell Medica in requesting a waiver of any such obligation from the U.S. government where such manufacture is not reasonably feasible.

13.3Export Control Regulations. The Licensed Product, Licensed Technology and Patent Rights are subject to, and Cell Medica agrees to comply in all respects with, U.S. law including but not limited to U.S. export controls under the Export Administration Regulations (15 C.F.R. Part 734 et seq.) and U.S. economic sanctions and embargoes codified in 31 C.F.R. Chapter V. Cell Medica agrees that Cell Medica bears sole responsibility for understanding and complying with current U.S. trade controls laws and regulations as applicable to its activities subject to this Agreement. Without limitation on the general agreement to comply set forth in the first sentence of this Section 13.3, Cell Medica agrees not to sell any goods, services, or technologies subject to this Agreement, or to release or disclose or re-export the same: (i) to any destination prohibited by U.S. law, including any destination subject to U.S. economic embargo; (ii) to any end-user prohibited by U.S. law, including any person or entity listed on the U.S. government's Specially Designated Nationals list, Denied Parties List, Debarred Persons List, Unverified List, or Entities List; (iii) to any foreign national in the U.S. or abroad without prior license if required; or (iv) to any user, for any use, or to any destination without prior license if required. Furthermore, Cell Medica agrees that any transfer of Patent Rights from Baylor to Cell Medica under this Agreement is subject to U.S. export license authorization as may be required under U.S. law.

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Article XIV
DISPUTE RESOLUTION

14.1 Amicable Resolution. The Parties shall attempt to settle any controversy between them and arising under this Agreement amicably. To this end, a senior executive from each Party shall consult and negotiate in good faith to reach a solution. The Parties agree that the period of amicable resolution shall toll any otherwise applicable statute of limitations. If the senior executives from each Party fail to meet, or if the matter remains unresolved, for a period of thirty (30) days from the date such controversy first was raised with the other party by notice delivered under Section  15.1, either Party shall have the right to seek to settle the controversy by binding arbitration pursuant to Section 14.2.

14.2Arbitration.

(a)Subject to Sections 14.3 and 14.4, any dispute, controversy, or claim arising out of or relating to this Agreement, or the breach, termination or invalidity thereof, including claims for tortious interference or other tortious or statutory claims arising before, during or after termination, providing only that such claim touches upon matters covered by this Agreement, shall be finally settled by arbitration administered by the American Arbitration Association pursuant to the Commercial Arbitration Rules in force at the time of the commencement of the arbitration, except as modified by the specific provisions of this Agreement. It is the specific intent of the Parties that this arbitration provision is intended to be the broadest form allowed by law. This agreement to arbitrate is intended to be binding upon the signatories hereto, their principals, successors, assigns, subsidiaries and Affiliates.

(b)The Parties agree that a final judgment on the arbitration award shall be binding, final and non-appealable other than for grounds to vacate the final award, and may be entered by any court having jurisdiction thereof.

(c)A panel of three arbitrators shall be appointed to conduct the arbitration, with each Party having the right to select one arbitrator, both of whom will agree on a third arbitrator to act as the chair of the panel. All three of such arbitrators shall be neutrals, i.e., having no affiliation with either Party.

(d)Each arbitrator must be an active or retired lawyer, having practiced actively in the field of commercial law and/or the law relevant to the subject matter of the arbitration, in each case, for at least fifteen (15) years.

(e)The law applicable to the validity of the arbitration clause, the conduct of the arbitration, including any resort to a court for provisional remedies, the enforcement of any award and any other question of arbitration law or procedure shall be the Federal Arbitration Act. The New York Convention on the Recognition and Enforcement of Foreign Arbitral Awards of June 10, 1958 shall govern any and all disputes that may be the subject of arbitration pursuant to this Agreement.

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(f)The arbitrator(s) shall hear and determine any preliminary issue of law asserted by a Party to be dispositive of any claim, in whole or part, in the manner of a court hearing a motion to dismiss for summary judgment, pursuant to such terms and procedures as the arbitrator(s) deems appropriate.

(g)The Parties and the arbitrator(s) shall treat all aspects of the arbitration proceedings, including without limitation discovery, testimony and other evidence, briefs and the award, as strictly confidential. Further, except as may be required by law, neither Party nor the arbitrator(s) may disclose the existence, content, or results of any arbitration hereunder without the prior written consent of both Parties.

(h)The seat of arbitration shall be New York, New York, USA.

(i)The arbitration shall be conducted in the English language. All submissions shall be made in English or with an English translation. Witnesses may provide testimony in a language other than English, provided that a simultaneous English translation is provided. Each Party shall bear its own translation costs.

14.3Injunctive Relief. Notwithstanding anything in this Agreement to the contrary, a Party may seek a temporary restraining order or a preliminary injunction from any court of competent jurisdiction, at any time, in order to prevent immediate and irreparable injury, loss, or damage on a provisional basis, pending the resolution of any dispute hereunder.

14.4Construction and Jurisdiction. This Agreement shall be deemed to be subject to, and have been made under, and shall be construed and interpreted in accordance with the laws of the State of New York. No conflict-of-laws rule or law that might refer such construction and interpretation to the laws of another state, republic, or country shall be considered.

Article XV
NOTICES

15.1Addresses for Notices. All notices, demands or other communications to be given or delivered under or by reason of the provisions of this Agreement shall be in writing and shall be deemed to have been given: (i) when delivered personally to the recipient to the address set forth below, if sent to the recipient by reputable express courier service (charges prepaid), or mailed to the recipient by certified or registered mail, return receipt requested and postage prepaid, or (ii) when sent to the recipient by electronic mail to the electronic mail address set forth below and the recipient has confirmed receipt of such electronic mail (and such confirmation of receipt can be confirmed by email). Such notices, demands and other communications shall be sent to the Parties at the addresses indicated below:

If to Baylor

If to Cell Medica

 

 

Baylor College of Medicine

Kuur Therapeutics Limited

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[*]

[*]

 

 

 

 

 

 

Attn: [*]

Attn: [*]

 

Chief Executive Officer

 

Tel. No: [*]

 

E-Mail:

 

[*]

 

 

With copy (which shall not constitute notice) to:

With copy (which shall not constitute notice) to:

[*]

[*]

 

 

 

 

Attn: [*]

Attn: [*]

E-Mail:

E-Mail:

[*]

[*]

 

15.2Use of Reference Number. Each such report, notice or other communication shall include BLG number(s) XX-XXX listed in Article I of this Agreement or the applicable BLG number as updated under Schedule C.

Article XVI
INDEMNITY, INSURANCE, AND WARRANTIES

16.1Indemnity.

(a)EACH PARTY SHALL NOTIFY THE OTHER OF ANY THIRD PARTY’S CLAIM, LAWSUIT OR OTHER PROCEEDING RELATED TO THE LICENSED TECHNOLOGY, LICENSED PRODUCTS, AND TECHNOLOGY RIGHTS.

(b)CELL MEDICA AGREES THAT IT WILL DEFEND, INDEMNIFY AND HOLD HARMLESS BAYLOR AND ITS AFFILIATES AND THEIR RESPECTIVE FACULTY MEMBERS, SCIENTISTS, RESEARCHERS, EMPLOYEES, STUDENTS, OFFICERS, TRUSTEES AND AGENTS (OTHER THAN ANY SUBLICENSEE OR OTHER PARTY TO WHOM BAYLOR HAS CONVEYED ITS RESERVED RIGHTS UNDER SECTION 2.4 WHICH SUCH PARTIES SHALL NOT BE DEEMED AGENTS OF BAYLOR) AND EACH OF THEM (THE “BAYLOR INDEMNIFIED PARTIES”), FROM AND AGAINST, AND SHALL PAY BAYLOR THE MONETARY VALUE OF, ALL LIABILITIES AND LOSSES RELATED TO OR RESULTING FROM, DIRECTLY OR INDIRECTLY, ANY AND ALL THIRD PARTY CLAIMS, CAUSES OF ACTION, LAWSUITS OR OTHER PROCEEDINGS (THE “BAYLOR CLAIMS”) FILED OR OTHERWISE INSTITUTED AGAINST ANY OF THE BAYLOR INDEMNIFIED PARTIES RELATED DIRECTLY OR INDIRECTLY TO OR ARISING OUT OF THE DESIGN, PROCESS, MANUFACTURE OR USE BY OR ON BEHALF OF CELL MEDICA, ITS AFFILIATES AND ITS SUBLICENSEES OF LICENSED TECHNOLOGY, PATENT RIGHTS, AND LICENSED PRODUCTS OR ANY OTHER

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EMBODIMENT OF THE LICENSED TECHNOLOGY, LICENSED PRODUCTS, AND PATENT RIGHTS EVEN THOUGH SUCH BAYLOR CLAIMS AND THE COSTS (INCLUDING, BUT NOT LIMITED TO, THE PAYMENT OF ALL REASONABLE ATTORNEYS' FEES AND COSTS OF LITIGATION OR OTHER DEFENSE) RELATED THERETO RESULT IN WHOLE OR IN PART FROM THE NEGLIGENCE OF ANY OF THE BAYLOR INDEMNIFIED PARTIES OR ARE BASED UPON DOCTRINES OF STRICT LIABILITY OR PRODUCT LIABILITY; PROVIDED, HOWEVER, THAT SUCH INDEMNITY SHALL NOT APPLY TO ANY BAYLOR CLAIMS TO THE EXTENT SUCH CLAIMS (1) ARISE FROM THE GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT OF, OR BREACH OF THIS AGREEMENT OR THE CO-DEVELOPMENT AGREEMENT BY, ANY BAYLOR INDEMNIFIED PARTY, OR (2) ARE SUBJECT TO BAYLOR’S INDEMNIFICATION OBLIGATIONS SET FORTH IN SECTION 16.1(c) OF THIS AGREEMENT OR SECTION 9.5(c) OF THE CO-DEVELOPMENT AGREEMENT. CELL MEDICA WILL ALSO ASSUME RESPONSIBILITY FOR ALL COSTS AND EXPENSES RELATED TO SUCH BAYLOR CLAIMS FOR WHICH IT IS OBLIGATED TO INDEMNIFY THE BAYLOR INDEMNIFIED PARTIES PURSUANT TO THIS SECTION 16.1, INCLUDING, BUT NOT LIMITED TO, THE PAYMENT OF ALL REASONABLE ATTORNEYS' FEES AND COSTS OF LITIGATION OR OTHER DEFENSE.

(c)BAYLOR AGREES THAT IT WILL DEFEND, INDEMNIFY AND HOLD HARMLESS CELL MEDICA AND ITS AFFILIATES AND THEIR RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES AND AGENTS AND EACH OF THEM (THE “CELL MEDICA INDEMNIFIED PARTIES”), FROM AND AGAINST, AND SHALL PAY CELL MEDICA THE MONETARY VALUE OF, ALL LIABILITIES AND LOSSES RELATED TO OR RESULTING FROM, DIRECTLY OR INDIRECTLY, ANY AND ALL CLAIMS, CAUSES OF ACTION, LAWSUITS OR OTHER PROCEEDINGS (THE “CELL MEDICA CLAIMS”) FILED OR OTHERWISE INSTITUTED AGAINST ANY OF THE CELL MEDICA INDEMNIFIED PARTIES BY OR ON BEHALF OF [*] ARISING OUT OF BAYLOR’S BREACH OF ITS REPRESENTATIONS AND WARRANTIES UNDER SECTION 16.8(a) OF THIS AGREEMENT; PROVIDED, HOWEVER, THAT SUCH INDEMNITY SHALL NOT APPLY TO ANY CELL MEDICA CLAIMS TO THE EXTENT ARISING FROM GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT OF, OR THE BREACH OF THIS AGREEMENT OR THE CO-DEVELOPMENT AGREEMENT BY ANY CELL MEDICA INDEMNIFIED PARTY. BAYLOR WILL ALSO ASSUME RESPONSIBILITY FOR ALL COSTS AND EXPENSES RELATED TO SUCH CELL MEDICA CLAIMS FOR WHICH IT IS OBLIGATED TO INDEMNIFY THE CELL MEDICA INDEMNIFIED PARTIES PURSUANT TO THIS SECTION 16.1, INCLUDING, BUT NOT LIMITED TO, THE PAYMENT OF ALL REASONABLE ATTORNEYS' FEES AND COSTS OF LITIGATION OR OTHER DEFENSE.

(d)THE PARTY SEEKING INDEMNIFICATION UNDER THIS SECTION 16.1 SHALL NOTIFY THE INDEMNIFYING PARTY WITHOUT UNDUE DELAY IN WRITING OF ANY CLAIM FOR WHICH IT SEEKS INDEMNITY HEREUNDER AND COOPERATE REASONABLY WITH THE INDEMNIFYING PARTY AT THE INDEMNIFYING PARTY’S SOLE COST AND EXPENSE. THE INDEMNIFYING PARTY SHALL PROMPTLY, AFTER BEING SO NOTIFIED, ASSUME THE DEFENSE OF ANY SUCH CLAIM WITH COUNSEL OF ITS CHOICE THAT IS REASONABLY

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SATISFACTORY TO THE INDEMNIFIED PARTY. THE INDEMNIFYING PARTY SHALL NOT SETTLE ANY SUCH CLAIM WITHOUT THE INDEMNIFIED PARTY’S PRIOR WRITTEN CONSENT UNLESS THE ONLY OBLIGATION AND LIABILITY OF, AND THE ONLY ADVERSE IMPACT ON, THE INDEMNIFIED PARTIES IS A PAYMENT OBLIGATION INDEMNIFIED IN FULL BY THE INDEMNIFYING PARTY. SUBJECT TO THE INDEMNIFYING PARTY’S RIGHT TO CONTROL THE DEFENSE AND SETTLEMENT THEREOF, THE INDEMNIFIED PARTY MAY PARTICIPATE IN AND OBSERVE THE PROCEEDINGS AT ITS OWN COST AND EXPENSE WITH COUNSEL OF ITS OWN CHOOSING.

16.2Insurance.

(a)Cell Medica shall for so long as Cell Medica manufactures or uses any Licensed Technology, Patent Rights, or Licensed Product under this Agreement, Cell Medica shall maintain in full force and effect policies of (a) worker's compensation insurance within statutory limits, (b) employers' liability insurance with limits of not less than one million U.S. dollars ($1,000,000) per occurrence, (c) general liability insurance (with Broad Form General Liability endorsement) with limits of not less than one million U.S. dollars ($1,000,000) per occurrence with an annual aggregate of two million U.S. dollars ($2,000,000) and (d) upon initiation of any human clinical study of a Licensed Product, products liability insurance, with limits of not less than three million U.S. dollars ($3,000,000) per occurrence with an annual aggregate of five million U.S. dollars ($5,000,000) unless liability associated with such clinical study is otherwise assumed by the United States government or other governmental entity.

(b)Notwithstanding Section 16.2(a), following regulatory approval for a Licensed Product, Cell Medica shall for so long as Cell Medica commercially manufactures or sells any such Licensed Product(s), also maintain in full force and effect policies of (a) worker's compensation insurance within statutory limits, (b) employers' liability insurance with limits of not less than one million U.S. dollars ($1,000,000) per occurrence, (c) general liability insurance (with Broad Form General Liability endorsement) with limits of not less than twenty million U.S. dollars ($20,000,000) per occurrence with an annual aggregate of forty million U.S. dollars ($40,000,000) and (d) products liability insurance, with limits of not less than twenty million U.S. dollars ($20,000,000) per occurrence with an annual aggregate of forty million U.S. dollars ($40,000,000); provided that if annual sales of Licensed Products are less than one hundred million U.S. dollars ($100,000,000), the insurance limits set forth above may be reduced to 0.2x projected sales per instance during the coverage year with 2x that amount in aggregate (for purposes of example only, if sales of Licensed Products are projected to be fifty million U.S. dollars ($50,000,000), each of the general liability and products liability coverage requirements would be ten million U.S. dollars ($10,000,000) per instance and twenty million U.S. dollars ($20,000,000) in aggregate).

(c)Such coverage(s) shall be purchased from a carrier or carriers having an A. M. Best rating of at least A- (A minus) and shall name Baylor as an additional insured. Cell Medica shall provide to Baylor copies of certificates of insurance within thirty (30) days after the Effective Date. Upon request by Baylor, Cell Medica shall provide to

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Baylor copies of said policies of insurance. It is the intention of the Parties hereto that Cell Medica shall, throughout the Term of this Agreement, continuously and without interruption, maintain in force the required insurance coverages set forth in this Section 16.2. Failure of Cell Medica to comply with this requirement shall constitute an Essential Breach of Cell Medica allowing Baylor, at its option, to terminate this Agreement in accordance with Section 11.1(b).

(d)Baylor reserves the right to request additional policies of insurance where appropriate and reasonable in light of Cell Medica’s business operations and availability of coverage.

16.3DISCLAIMER OF WARRANTY. EXCEPT AS EXPRESSLY SET FORTH IN SECTIONS 16.5, 16.8 and 16.9, BAYLOR MAKES NO WARRANTIES OR REPRESENTATIONS, AND HEREBY DISCLAIMS ALL WARRANTIES AND REPRESENTATIONS, RELATED TO THIS AGREEMENT AND ANY PERFORMANCE OR ACTIVITY HEREUNDER, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OR REPRESENTATIONS, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF FITNESS OR MERCHANTABILITY OR WORKMANSHIP, REGARDING OR WITH RESPECT TO THE LICENSED TECHNOLOGY, PATENT RIGHTS OR LICENSED PRODUCTS AND BAYLOR MAKES NO WARRANTIES OR REPRESENTATIONS, EXPRESS OR IMPLIED, OF THE PATENTABILITY OF THE LICENSED TECHNOLOGY, LICENSED PRODUCTS, PATENT RIGHTS OR LICENSED PRODUCTS OR OF THE ENFORCEABILITY OF ANY PATENTS ISSUING THEREUPON, IF ANY, OR THAT THE LICENSED TECHNOLOGY, PATENT RIGHTS OR LICENSED PRODUCTS ARE OR SHALL BE FREE FROM INFRINGEMENT OF ANY PATENT OR OTHER RIGHTS OF THIRD PARTIES. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS CONFERRING BY IMPLICATION, ESTOPPEL OR OTHERWISE ANY LICENSE OR RIGHTS UNDER ANY PATENTS OF BAYLOR OTHER THAN THE PATENT RIGHTS, REGARDLESS OF WHETHER SUCH PATENTS ARE DOMINANT OR SUBORDINATE TO THE PATENT RIGHTS.

16.4EXCLUSION AND LIMITATION OF LIABILITY. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER, OR ANYBODY CLAIMING THROUGH SUCH OTHER PARTY FOR ANY CONSEQUENTIAL, INCIDENTAL, PUNITIVE, SPECIAL, OR LIQUIDATED DAMAGES OR LOSS, INCLUDING, WITHOUT LIMITATION, LOST BUSINESS OR LOST PROFITS, OF ANY KIND UNDER OR IN CONNECTION WITH THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, ANY SUCH DAMAGES THAT ARISE FROM ANY USE OF ANY LICENSED TECHNOLOGY OR FROM ANY LICENSED PRODUCT. IF BAYLOR IS LIABLE FOR ANY DIRECT DAMAGES OR LOSSES UNDER THIS AGREEMENT, OR FOR ANY DAMAGES OR LOSSES THAT CANNOT BE VALIDLY EXCLUDED UNDER THE FOREGOING PROVISION OF THIS SECTION 16.4, THE TOTAL AND AGGREGATE DAMAGES AND LOSSES FOR WHICH BAYLOR IS LIABLE UNDER THIS AGREEMENT SHALL BE LIMITED IN THE AGGREGATE TO (A) THE SUM OF THE ROYALTIES AND OTHER LICENSE OR OPTION FEES PAID BY CELL MEDICA TO BAYLOR UNDER THIS AGREEMENT WITHIN TWELVE (12) MONTHS PRIOR TO ASSERTING SUCH CLAIM

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FOR SUCH DAMAGES AND LOSSES, OR (B) WITH RESPECT TO BAYLOR’S INDEMNIFICATION UNDER SECTION 16.1(c) THE SUM OF THE ROYALTIES AND OTHER LICENSE OR OPTION FEES PAID BY CELL MEDICA TO BAYLOR UNDER THIS AGREEMENT WITHIN TWENTY-FOUR (24) MONTHS PRIOR TO ASSERTING SUCH CLAIM FOR SUCH DAMAGES AND LOSSES.

16.5Representations and Warranties. Each Party represents and warrants to the other Party that as of the Effective Date:

(a)it has the full right, power and authority to enter into this Agreement, and to perform its obligations hereunder; and

(b)this Agreement has been duly executed by it and is legally binding upon it, enforceable in accordance with its terms, and does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it.

16.6Covenants of Cell Medica. Cell Medica shall not, during the Term, hire, engage, contract, employ or otherwise seek to acquire or acquire any services of Dr. Metelitsa or any member of Dr. Metelitsa’s laboratory other than as provided under this Agreement, the Co-Development Agreement, and any Specific Industrial Research Agreement or Specific Industrial Clinical Research Agreement.

16.7Representations and Warranties of Cell Medica.

(a)Neither Party’s conduct of its activities pursuant to the Development Plan as it exists as of the Effective Date and in accordance with the terms of the Co-Development Agreement, to the knowledge of Cell Medica, will breach any written agreement between Cell Medica and any Third Party, nor give rise to a right by any such Third Party to enforce any Technology Right licensed to Cell Medica by such Third Party.

(b)Cell Medica is duly incorporated, in existence and registered under the laws of England and Wales.

(c)Cell Medica Inc. is duly incorporated, in existence and registered under the laws of Texas and is wholly owned by Cell Medica.

(d)Cell Medica GmbH is duly incorporated, in existence and registered under the laws of Germany and is wholly owned by Cell Medica.

(e)The issued share capital of Cell Medica immediately prior to the Initial Equity Closing will be 2,053,486 Ordinary Shares, 3,686,968 A Preference Shares, and 6,993,007 B Preference Shares. Such Shares constitute the entire issued share capital of Cell Medica and are fully paid up.

(f)Save for the allotment and issue of BCM Preference Shares or Relevant Securities pursuant to this Agreement or as contemplated by the Shareholders

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Agreement or the Articles of Association, no Group Company has agreed to issue or grant any other Relevant Securities following the Initial Equity Closing.

(g)No step has been taken to initiate any process by or under which:

(i)the ability of the creditors of any of the Group Companies to take any action to enforce their debts is suspended, restricted or prevented;

(ii)some or all of the creditors of the Group Companies accept, by agreement or under a court order, an amount less than the sums owing to them in satisfaction of those sums with a view to preventing the dissolution of any Group Company;

(iii)a person is appointed to manage the affairs, business and assets of any Group Company on behalf of their respective creditors; or

(iv)the holder of a charge over any Group Company's assets is appointed to control the business and assets of any Group Company.

(h)In relation to each Group Company:

(i)no administrator has been appointed;

(ii)no documents have been filed with the court for the appointment of an administrator; and

(iii)no notice of an intention to appoint an administrator has been given by the relevant company, its directors or by a qualifying floating charge holder (as defined in paragraph 14 of Schedule B1 to the United Kingdom Insolvency Act 1986).

16.8Representations and Warranties of Baylor. Baylor represents and warrants to Cell Medica that as of the Effective Date:

(a)Baylor’s Office of General Counsel has no actual knowledge of (i) any written claim made against it asserting the invalidity, or unenforceability or non-infringement of any of the Core Platform Patent Rights or Baylor Target Patent Rights or (ii) any written claim made against it challenging Baylor’s ownership of the Core Platform Patent Rights or Baylor Target Patent Rights or making any adverse claim of ownership (whether sole or joint) thereof or license thereto;

(b)Baylor’s Office of General Counsel and the Baylor Licensing Group have no actual knowledge of any written agreement granting to any Third Party a license, an option to acquire a license, or a covenant not to sue under any of the Core Platform Patent Rights, Baylor Target Patent Rights or any Core Subject Technology to research, develop, make, use, offer for sale, sell, or otherwise commercialize a Licensed Product in any field, which license, option or covenant not to sue has not expired or been terminated prior to the Effective Date, and which license, option or covenant not to sue would conflict with any license right granted to Cell Medica under this Agreement, other than (i) to academic or non-profit entities, pursuant to federal or state laws related to

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government-sponsored research, (iii) the [*], and (iii) the SIRAs or SICRAs executed pursuant to the Co-Development Agreement;

(c)Baylor’s Office of General Counsel and the Baylor Licensing Group have no actual knowledge of any written agreement granting to any Third Party a license, an option to acquire a license, or a covenant not to sue under any of the Core Platform Patent Rights or any Core Subject Technology (but excluding the Baylor Target Patent Rights and the NKT CAR Subject Technology) which license, option or covenant not to sue has not expired or been terminated prior to the Effective Date, and which license, option or other right would conflict with the options granted hereunder to Future Products, Future Oncology Technology and Future Non-Oncology Technology, other than (i) to academic or non-profit entities, (ii) pursuant to federal or state laws related to government-sponsored research, and (iii) pursuant to the [*];

(d)Baylor’s Office of General Counsel has no actual knowledge of any written claim, legal action, or judgment or settlement of infringement of any patent rights of any Third Party made against Baylor or any of its Affiliates asserting such infringement by the manufacture of any current Licensed Core Product.

(e)Neither Party’s conduct of its activities pursuant to the Development Plan as it exists as of the Effective Date and in accordance with the terms of the Co-Development Agreement, to the knowledge of Baylor’s Office of General Counsel, will breach any written agreement between Baylor and any Third Party, nor give rise to a right by any such Third Party to enforce any Technology Right licensed to such Third Party by Baylor.

16.9Baylor Private Placement Representations and Warranties. Baylor represents and warrants to Cell Medica that as of the Effective Date and as of any date on which Cell Medica issues shares to Baylor pursuant to this Agreement; and Baylor further covenants to confirm by officer’s certificate on any future date on which Cell Medica issues shares to Baylor pursuant to this Agreement, if so requested by Cell Medica, the following:

(a)Baylor acknowledges that such shares are being issued for Baylor’s own account and not with the view to, or for resale in connection with, any distribution or public offering thereof within the meaning of the U.S. Securities Act of 1933, as amended (the “Securities Act”). Baylor understands that none of such shares have been registered under the Securities Act by reason of their issuance in transactions exempt from the registration and prospectus delivery requirements of the Securities Act pursuant to Section 4(a)(2) thereof, the availability of which depends upon, inter alia, the bona fide nature of Baylor’s intent and the accuracy of Baylor’s representations in this Agreement. Baylor further understands that such shares will bear the following legend and Baylor agrees that it will hold such shares subject thereto:

“THESE SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, AND HAVE NOT BEEN

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ACQUIRED WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE OR DISTRIBUTION THEREOF. NO TRANSFER OF THESE SECURITIES MAY BE EFFECTED WITHOUT AN EFFECTIVE REGISTRATION STATEMENT RELATED THERETO OR AN OPINION OF COUNSEL IN A FORM SATISFACTORY TO THE ISSUER AND/OR THE SUBMISSION TO THE ISSUER OF SUCH OTHER EVIDENCE AS MAY, IN THE ISSUER’S SOLE DISCRETION, BE SATISFACTORY TO THE ISSUER TO THE EFFECT THAT SUCH REGISTRATION IS NOT REQUIRED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.”

Baylor acknowledges that Cell Medica need not register a transfer of legended shares unless the conditions specified in the legend are satisfied.

(b)Baylor has such knowledge and experience in financial and business matters that it is capable of independently evaluating the risks and merits of the acquiring such shares; Baylor has independently evaluated the risks and merits of acquiring such shares and has independently determined that such shares are a suitable investment for it; Baylor has sufficient financial resources to bear the loss of its entire investment in such shares; and Baylor has had the opportunity to review this Agreement and the Exhibits and Schedules hereto and thereto and the transactions contemplated by this Agreement with its own legal counsel.

(c)Baylor believes, after due inquiry and investigation, that it has received all of the information that it considers necessary or appropriate for deciding whether to acquire such shares. Baylor further represents that it has had an opportunity to ask questions and receive answers from Cell Medica regarding the terms and conditions of the issuance of such shares by Cell Medica and the business, properties, prospects and financial condition of Cell Medica and to obtain additional information (to the extent Cell Medica possessed such information or could acquire it without unreasonable effort or expense) necessary to verify the accuracy of any information furnished to Baylor.

(d)Baylor acknowledges that such shares may not be sold in the United States unless subsequently registered under the Securities Act or unless an exemption from such registration is available. Baylor is aware of the provisions of Rule 144 promulgated under the Securities Act which permit limited resale of securities purchased in a private placement subject to the satisfaction of certain conditions.

(e)Baylor is an “accredited investor” as defined in Rule 501(a)(3) of Regulation D promulgated under the Securities Act.

(f)Baylor’s address set forth in this Agreement is the office of Baylor’s principal place of business, upon which Cell Medica may rely for the purpose of complying with applicable state securities or “Blue Sky” laws. Baylor shall cooperate, to the extent commercially reasonable, with Cell Medica in any applicable state securities or “Blue Sky” filings.

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16.10Fourth Amendment Effective Date Representations and Warranties of Baylor.

(a)Baylor represents and warrants to Cell Medica that as of the effective date of the Fourth Amendment to this Agreement dated December 19, 2018 (the “Fourth Amendment”):

(b)Baylor has delivered to [*] a letter on or around January 29, 2018 terminating for cause the [*]in accordance with its terms (the "Termination Letter");

(c)since delivery of the Termination Letter, Baylor received from [*] an oral request to extend the cure period substantially beyond the cure period required under the [*] Agreement, which request Baylor declined in writing to [*] on April 8, 2018;

(d)To Baylor's knowledge, [*] has not refuted Baylor's bases for terminating the [*] Agreement and has made no attempt to cure;

(e)Upon termination of the [*] Agreement, Baylor resumed control of the patent and patent application assets that had been licensed to and controlled by [*] under the [*] Agreement ("Subject Patents");

(f)To Baylor's knowledge, [*] has not opposed Baylor resuming prosecution of the Subject Patents

(g)Baylor has received no further correspondence from [*] of any nature regarding the [*] Agreement.

Article XVII
CONFIDENTIALITY AND NON-DISCLOSURE

17.1Scope. Neither Party, as the Receiving Party, shall, directly or indirectly, divulge or reveal to any person or entity the Confidential Information of the other Party without the Disclosing Party’s prior written consent, or use such Confidential Information except as permitted under this Agreement or the Co-Development Agreement. Subject to Section 17.2, Cell Medica shall maintain the Licensed Technology and unpublished Patent Rights in strictest confidence and use the same only in accordance with this Agreement, the Co-Development Agreement or any other written agreements with Baylor. Employees, agents or subcontractors of the Receiving Party shall be given access to the Disclosing Party’s Confidential Information only on a reasonable “need to know” basis and after agreeing to be legally bound to protect the Confidential Information in a manner consistent with this Article  XVII. The public disclosure (with or without the permission of the Disclosing Party) of any one component of that which was identified as or constituted the Confidential Information of the Disclosing Party shall not prevent the other components from retaining their status as Confidential Information and the property of such Party. In addition, Baylor shall maintain all of its Confidential Information that is subject to Cell Medica’s licenses and options hereunder in the same manner as it is

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obligated to treat Cell Medica’s Confidential Information under this Article XVII, subject to Section 17.5.

17.2Exclusion. Such obligation of confidentiality shall not apply to information (including any Patent Rights or Licensed Technology) which the Receiving Party can demonstrate through competent evidence: (i) was at the time of disclosure in the public domain; (ii) has come into the public domain after disclosure through no breach of this Agreement or the Co-Development Agreement by the Receiving Party; (iii) was known to the Receiving Party prior to disclosure thereof by the Disclosing Party; (iv) was lawfully disclosed to the Receiving Party by a Third Party which was not under an obligation of confidence to the Disclosing Party with respect thereto; (v) was disclosed pursuant to Section 17.3; or (vi) was approved for public release by prior written permission of the Disclosing Party.

17.3Authorized Disclosure. A Receiving Party may disclose Confidential Information of the Disclosing Party or the terms of this Agreement:

(a)To such Receiving Party’s Affiliates and, as applicable, sublicensees; provided that such Affiliates and/or sublicensees are bound by legally enforceable obligations to maintain the confidentiality of the Disclosing Party’s Confidential Information in a manner consistent with the confidentiality provisions of this Agreement;

(b)To employees, directors, agents, contractors, consultants and advisers of the Receiving Party and its Affiliates and sublicensees, its legal counsel, and legal counsel representing any of the foregoing, including, without limitation, the individuals and entities listed in Exhibit B, in each case to the extent reasonably necessary for the purposes of, and for those matters undertaken pursuant to, this Agreement; provided that each such individual and entity is bound by legally enforceable obligations to maintain the confidentiality of the Disclosing Party’s Confidential Information in a manner consistent with the confidentiality provisions of this Agreement; and further provided that each Party shall remain responsible for any failure by its Affiliates and sublicensees, and its Affiliates’ and sublicensees’ respective employees, directors, agents, consultants, advisors, and contractors, to treat such Confidential Information as required under this Article XVII (as if such Affiliates, licensees, sublicensees employees, directors, agents, consultants, advisors and contractors were Parties directly bound to the requirements of this Article XVII);

(c)To the extent such disclosure is reasonably necessary in the following situations:

(i)filing or prosecuting of Patent Rights as contemplated by this Agreement or conducting or defending litigation;

(ii)submitting regulatory filings and other filings with governmental authorities (including Regulatory Authorities);

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(iii)complying with Applicable Laws, including regulations promulgated by securities exchanges, it being expressly understood that Cell Medica shall have the right to disclose the existence and terms of this Agreement, the Co-Development Agreement and status of activities conducted hereunder and thereunder in connection with its IPO, as required by applicable Law and/or any securities exchange rules on which it lists its shares in such IPO, or in connection with subsequent public filings as required under Applicable Laws or such securities exchange rules;

(d)to a Party’s Affiliates, directors, employees, agents, independent contractors, licensors, attorneys, independent accountants or financial advisors on a need-to-know basis for the sole purpose of performance of this Agreement or the Co-Development Agreement or providing advice with respect to this Agreement or the Co-Development Agreement, provided that in each such case on the condition that such disclosee is bound by confidentiality and non-use obligations substantially consistent with those contained in this Agreement;

(e)to actual or bona fide potential investors, acquirors, sublicensees and other financial or commercial partners solely for the purpose of evaluating or carrying out an actual or potential investment, acquisition, license or collaboration (and any attorney, accountant or other advisor, of the Receiving Party or any of its Affiliates, advising on such matter); provided that in each such case on the condition that such persons are bound by confidentiality and non-use obligations substantially consistent with those contained in this Agreement, save that such obligations may be for a term of no less than five (5) years following the disclosure of such Confidential Information to such persons; and further provided that in each such case where such Confidential Information is also entitled to attorney-client privilege, the attorney work product privilege, or any other similar privilege, protection, or immunity (“Privileged and Confidential Information”), the Receiving Party shall ensure that each such actual or bona fide potential investor, acquiror, sublicensee and other financial or commercial partner (or attorney, accountant or other advisor) has a common legal interest with the Disclosing Party and the Receiving Party at the time of disclosure and that such Privileged and Confidential Information is disclosed solely pursuant to a written common interest agreement sufficient to protect the privileged status of such Privileged and Confidential Information; and

(f)where such disclosure is required by judicial or administrative process, provided that in such event such Party shall promptly notify the other Party in writing of such required disclosure and provide the other Party an opportunity to challenge or limit the disclosure obligations. Confidential Information that is disclosed by judicial or administrative process shall remain otherwise subject to the confidentiality and non-use provisions of this Article XVII, and the Party disclosing Confidential Information pursuant to law or court order shall take all steps reasonably necessary, including seeking of confidential treatment or a protective order, to ensure the continued confidential treatment of such Confidential Information.

17.4Confidentiality of Agreement. Unless otherwise provided for in this Agreement, the Parties agree that this Agreement and the Co-Development Agreement

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and their terms are to be considered Confidential Information of each Party and shall be treated as such.

17.5Publication. Each Party will provide the other Party with a copy of any proposed publication or other disclosure, including by any Third Party that is a party to a SIRA or SICRA (each, as defined in the Co-Development Agreement), of:

(a)Core Subject Technology and/or Future Technology and/or

(b)relating to activities conducted pursuant to the Co-Development Agreement,

for review and comment at least sixty (60) days prior to submission for publication or other disclosure (the “Publication Review Period”). Each Party will cooperate with the other Party regarding the publication or other disclosure as finalized, including, without limitation and at the Disclosing Party’s election, deleting any of Disclosing Party’s Confidential Information specifically identified in writing by the Disclosing Party for deletion by the Receiving Party during the Publication Review Period, and/or delaying publication or other disclosure for up to thirty (30) additional days to facilitate filing a patent application if so requested by the Receiving Party.

Article XVIII
ADDITIONAL PROVISIONS

18.1Use of Names.

(a)Cell Medica agrees that it shall not use in any way the name of "Baylor College of Medicine" or any logotypes or symbols associated with Baylor or any marks confusingly similar thereto or the names of any of the scientists or other researchers at Baylor without the prior written consent of Baylor.

(b)Notwithstanding Section 18.1(a) above, Cell Medica shall have the right:

(i)as required by Applicable Laws, to refer to Baylor as its licensor and to this Agreement and its related agreements in a factual manner, it being expressly understood that Cell Medica shall have the right to so refer to Baylor as its licensor and to this Agreement in connection with its IPO, as required by Applicable Law and/or any securities exchange on which it lists its shares in such IPO, or in connection with subsequent public filings as required under applicable Law or such securities exchanges; and

(ii)to make appropriate attribution to Baylor as a source of data in keeping with good scientific practice.

Nothing in this Section 18.1(b) shall relieve Cell Medica of its obligations under Article XVII with respect to the material with which such use of Baylor’s name is associated.

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(c)Baylor shall have the right, as required by Applicable Laws, to refer to Cell Medica as its licensee and to this Agreement and its related agreements in a factual manner. Baylor shall also have the right to so refer to Cell Medica as its licensee and to this Agreement in connection with its submissions regulatory, tax, and/or grant authorities. Nothing in this Section 18.1(c) shall relieve Baylor of its obligations under Article XVII with respect to the material with which such use of Cell Medica’s name is associated.

18.2Marketing of Licensed Products. To the extent commercially feasible and consistent with prevailing business practices, Cell Medica shall mark, and shall cause its sublicensees to mark, all Licensed Products that are manufactured or sold under this Agreement with the number of each issued patent under the Patent Rights that applies to such Licensed Product.

18.3Baylor’s Disclaimers. Neither Baylor, nor any of its faculty members, scientists, researchers, employees, students, officers, trustees or agents assume any responsibility for the manufacture, product specifications, sale or use of the Licensed Technology, Patent Rights or Licensed Products which are manufactured by or sold by Cell Medica.

18.4Remedies; Injunctive Relief. Each Party recognizes that any actual or potential violation, breach, or non-performance of, or default under, any provision in Article XVI may cause irreparable injury to the other Party for which such other Party may have no adequate remedy at law. Therefore, each Party agrees that such other Party shall be entitled to seek injunctive relief or specific performance, without need or obligation to post any bond, to enforce any obligation, agreement, covenant, term and condition under Article XVI, in addition to any other rights and remedies available to such other Party, all as the other Party elects in its sole discretion.

18.5Independent Contractors. The Parties hereby acknowledge and agree that each is an independent contractor and that neither Party shall be considered to be the agent, representative, master or servant of the other Party for any purpose whatsoever, and that neither Party has any authority to enter into a contract, to assume any obligation or to give warranties or representations on behalf of the other Party. Nothing in this relationship shall be construed to create a relationship of joint venture, partnership, fiduciary or other similar relationship between the Parties.

18.6Non-Waiver. The Parties covenant and agree that if a Party fails or neglects for any reason to take advantage of any of the terms provided for the termination of this Agreement or if a Party, having the right to declare this Agreement terminated, shall fail to do so, any such failure or neglect by such Party shall not be a waiver or be deemed or be construed to be a waiver of any cause for the termination of this Agreement subsequently arising, or as a waiver of any of the terms, covenants or conditions of this Agreement or of the performance thereof. None of the terms, covenants and conditions of this Agreement may be waived by a Party except by its written consent.

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18.7Severability. The Parties hereby agree that neither Party intends to violate any public policy, statutory or common law, rule, regulation, treaty or decision of any government agency or executive body thereof of any country or community or association of countries, and that if any word, sentence, paragraph or clause or combination thereof of this Agreement is found, by a court or executive body with judicial powers having jurisdiction over this Agreement or any of the Parties hereto, in a final, unappealable order to be in violation of any such provision in any country or community or association of countries, such words, sentences, paragraphs or clauses or combination shall be inoperative in such country or community or association of countries, and the remainder of this Agreement shall remain binding upon the Parties hereto. In lieu of such inoperative words, sentences, paragraphs or clauses, or combination of clauses, there will be added automatically as part of this Agreement, a valid, enforceable and operative provision as close to the original language as may be possible which preserves the economic benefits to the Parties.

18.8Force Majeure. No liability hereunder shall result to a Party by reason of delay in performance caused by force majeure, that is circumstances beyond the reasonable control of the Party, including, without limitation, acts of God, fire, flood, war, terrorism, civil unrest, labor unrest, or shortage of or inability to obtain material or equipment.

18.9Entire Agreement. The terms and conditions herein as well as those of the Co-Development Agreement, constitute the entire agreement between the Parties and shall supersede all previous agreements, whether electronic, oral or written, between the Parties hereto with respect to the subject matter hereof and thereof. No agreement of understanding bearing on this Agreement shall be binding upon either Party hereto unless it shall be in writing and signed by the duly authorized officer or representative of each of the Parties and shall expressly refer to this Agreement. Electronic communication between the Parties shall not constitute an agreement of understanding, unless it is subsequently reduced to writing and signed by the duly authorized officer or representative of each of the Parties and shall expressly refer to this Agreement.

18.10Counterparts. The Parties may execute this Agreement in multiple counterparts, each of which constitutes an original as against the Party that signed it, and all of which together constitute one agreement. This Agreement is effective upon delivery of one executed counterpart from each Party to the other Party. The signatures of the Parties need not appear on the same counterpart. The delivery of signed counterparts by facsimile or email transmission that includes a copy of the sending Party’s signature is as effective as signing and delivering the counterpart in person.

18.11Effect of Restatement. The Parties agree that this Restated Agreement supersedes and replaces the Original Agreement from and after the Restatement Effective Date. Notwithstanding the foregoing, the terms of the Original Agreement shall continue to apply with respect to matters that occurred prior to the Restatement Effective Date.

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18.1265(n) – Bankruptcy. The Parties hereby agree that the rights to the Technology, Patent Rights and other Technology Rights licensed by Baylor to Cell Medica under this Agreement (the “Licensed Intellectual Property”) constitute licenses of rights to “intellectual property” as defined in Section 101(35A) of the United States Bankruptcy Code and that this Agreement shall be governed by Section 365(n) of the United States Bankruptcy Code, as applicable, or any successor provision addressing this subject, in the event Baylor voluntarily or involuntarily becomes subject to the protection of the United States Bankruptcy Code and Baylor or the trustee in bankruptcy rejects this Agreement under the United States Bankruptcy Code (a “Triggering Event”). Upon the occurrence of a Triggering Event, Cell Medica shall have the right to: (a) treat this Agreement as terminated as set forth in 11 U.S.C. §365(n)(1)(A); or (b) retain Cell Medica’s rights under this Agreement, specifically including the right to exercise its rights granted herein to the Licensed Intellectual Property. Failure by Cell Medica to assert its right to retain its benefits to the Licensed Intellectual Property pursuant to Section 365(n)(1)(B) of the United States Bankruptcy Code with respect to an executory contract rejected by Baylor or the trustee in bankruptcy shall not be construed by the courts as a termination of such contract by Cell Medica under Section 365(n)(1)(A) of the United States Bankruptcy Code. Any attempted assignment of this Agreement by Baylor or the trustee in bankruptcy to a Third Party shall be subject to such Third Party providing “adequate assurance of future performance” (as referenced in Section 365(f) of the United States Bankruptcy Code or any successor provision addressing this subject) to Cell Medica.

[Signature page follows]

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IN WITNESS WHEREOF, the Parties hereto have executed and delivered this Agreement in multiple originals by their duly authorized officers and representatives on the respective dates shown below, but effective as of the Effective Date.

CELL MEDICA, LTD

 

BAYLOR COLLEGE OF MEDICINE

 

 

 

Name:

/s/ Kevin Boyle

 

Name:

/s/ Michael B. Dilling

 

Kevin S. Boyle

 

 

Michael B. Dilling, Ph.D., CLP

 

 

 

 

 

Title:

Chief Executive Officer

 

Title:

Director, Baylor Licensing Group

 

 

 

Date:

February 28. 2020

 

Title:

February 28. 2020

 

 

 

 

75

 

Exhibit 31.1

CERTIFICATION PURSUANT TO

SECTION 302 OF

THE SARBANES-OXLEY ACT OF 2002

I, Johnson Y.N. Lau, certify that:

1.

I have reviewed this Quarterly Report on Form 10-Q of Athenex, Inc. (the registrant);

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.

The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c)

Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d)

Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and

5.

The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions):

 

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and

 

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting.

Date: August 5, 2021

 

/s/ Johnson Y.N. Lau

Name:

 

Johnson Y.N. Lau

Title:

 

Chief Executive Officer and Board Chairman

(Principal Executive Officer)

 

 

 

Exhibit 31.2

CERTIFICATION PURSUANT TO

SECTION 302 OF

THE SARBANES-OXLEY ACT OF 2002

I, Randoll Sze, certify that:

1.

I have reviewed this Quarterly Report on Form 10-Q of Athenex, Inc. (the registrant);

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.

The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c)

Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d)

Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and

5.

The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions):

 

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and

 

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting.

Date: August 5, 2021

 

/s/ Randoll Sze

Name:

 

Randoll Sze

Title:

 

Chief Financial Officer

(Principal Financial and Accounting Officer)

 

 

 

Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In accordance with 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, Johnson Y.N. Lau, Chief Executive Officer and Board Chairman (Principal Executive Officer) of Athenex, Inc. (the registrant), and Randoll Sze, Chief Financial Officer of the registrant (Principal Financial and Accounting Officer), each hereby certifies that, to the best of their knowledge:

1.

The registrants Quarterly Report on Form 10-Q for the period ended June 30, 2021, to which this Certification is attached as Exhibit 32.1 (the Report), fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

2.

The information contained in the Report fairly presents, in all material respects, the financial condition of the registrant at the end of the period covered by the Report and results of operations of the registrant for the period covered by the Report.

 

 

 

Date: August 5, 2021

 

/s/ Johnson Y.N. Lau

Name:

 

Johnson Y.N. Lau

Title:

 

Chief Executive Officer and Board Chairman

(Principal Executive Officer)

 

/s/ Randoll Sze

Name:

 

Randoll Sze

Title:

 

Chief Financial Officer

(Principal Financial and Accounting Officer)